Clinical Trial Details
| Trial ID: | L1608 |
| Source ID: | NCT02876835 |
| Associated Drug: | Daprodustat |
| Title: | Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND) |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02876835/results |
| Conditions: | Anaemia |
| Interventions: | DRUG: Daprodustat|DRUG: Darbepoetin alfa|DRUG: Placebo|DRUG: Iron Therapy |
| Outcome Measures: | Primary: Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period (Non-inferiority Analysis), Time to MACE defined as time to first occurrence of Clinical Events Committee (CEC) adjudicated MACE (composite of all-cause mortality, non-fatal myocardial infarction \[MI\] and non-fatal stroke) was analyzed using a Cox proportional hazards regression model with treatment group, current erythropoiesis-stimulating agents (ESA) use at randomization and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) plus (+) 1. The incidence rate per 100 person years calculated as (100 multiplied \[\*\] number of participants with at least 1 event) divided by \[/\] first event person-years) is presented along with 95 percent (%) confidence interval (CI). First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period., Up to 4.3 person-years for CV follow-up time period|Mean Change From Baseline in Hgb Levels Over the Evaluation Period (Week 28 to Week 52), Blood samples were collected from participants for Hgb measurements. Hgb during the evaluation period was defined as the mean of all available post-randomization Hgb values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis missing post-Baseline Hgb values were imputed using pre-specified multiple imputation methods. Change from Baseline was defined as post-Baseline value minus (-) Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using the Analysis of covariance (ANCOVA) model with terms for treatment, Baseline Hgb, current ESA use and region., Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52) | Secondary: Time to First Occurrence of Adjudicated MACE During CV Events Follow-up Time Period (Superiority Analysis), Time to MACE defined as the time to first occurrence of CEC adjudicated MACE was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariate. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. This endpoint was adjusted for multiplicity using the Holm-Bonferonni method., Up to 4.3 person-years for CV follow-up time period|Time to First Occurrence of Adjudicated MACE or Thromboembolic Event During CV Events Follow-up Time Period, Time to first occurrence of adjudicated MACE or thromboembolic event (vascular access thrombosis, symptomatic deep vein thrombosis or symptomatic pulmonary embolism) was analyzed using a Cox proportional hazards regression model with with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. This endpoint was adjusted for multiplicity using the Holm-Bonferonni method., Up to 4.3 person-years for CV follow-up time period|Time to First Occurrence of Adjudicated MACE or Hospitalization for Heart Failure During CV Events Follow-up Time Period, Time to first occurrence of adjudicated MACE or hospitalization for heart failure was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. This endpoint was adjusted for multiplicity using the Holm-Bonferonni method., Up to 4.3 person-years for CV follow-up time period|Time to First Occurrence of Chronic Kidney Disease (CKD) Progression During CV Events Follow-up Time Period, Progression of CKD defined as: 40% decline in estimated glomerular filtration rate (eGFR) from Baseline or end stage renal disease (ESRD) as defined by either initiating chronic dialysis for \>=90 days or not initiating chronic dialysis when dialysis is indicated or kidney transplantation. Time to first occurrence of CKD progression was analyzed using Fine and Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) +1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period., Up to 4.3 person-years for CV follow-up time period|Time to First Occurrence of Adjudicated All-Cause Mortality During Vital Status for Follow-up Time Period, Time to first occurrence of adjudicated all-cause mortality was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the vital status follow-up time period., Up to 4.3 person-years for vital status follow-up time period|Time to First Occurrence of Adjudicated CV Mortality During CV Events Follow-up Time Period, Time to first occurrence of adjudicated CV mortality was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period., Up to 4.3 person-years for CV follow-up time period|Time to First Occurrence of Adjudicated Myocardial Infarction (MI) (Fatal and Non-Fatal) During CV Events Follow-up Time Period, Time to first occurrence of adjudicated MI (fatal and non-fatal) was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period., Up to 4.3 person-years for CV follow-up time period|Time to First Occurrence of Adjudicated Stroke (Fatal and Non-Fatal) During CV Events Follow-up Time Period, Time to first occurrence of adjudicated stroke (fatal and non-fatal) was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period., Up to 4.3 person-years for CV follow-up time period|Number of Participants With Adjudicated MACE or Hospitalization for Heart Failure (Recurrent Events Analysis), Number of participants with adjudicated MACE or hospitalization for heart failure (recurrent events analysis) is presented, categorized by number of occurrences of adjudicated MACE or hospitalization for heart failure per participant., Up to 4.3 person-years for CV follow-up time period|Time to First Occurrence of Adjudicated CV Mortality or Non-Fatal MI During CV Events Follow-up Time Period, Time to first occurrence of adjudicated CV mortality or non-fatal MI was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period., Up to 4.3 person-years for CV follow-up time period|Time to First Occurrence of All-Cause Hospitalization During CV Events Follow-up Time Period, All-cause hospitalization events were hospital admissions recorded on the hospitalization electronic case report form (eCRF) form with a hospitalization duration \>=24 hours. Time to first occurrence of all-cause hospitalization was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period., Up to 4.3 person-years for CV follow-up time period|Time to First Occurrence of All-Cause Hospital Re-admission Within 30 Days During CV Events Follow-up Time Period, All-cause hospital re-admissions within 30days are defined as hospital admissions recorded on hospitalization electronic case record form with hospitalization duration of \>=24 hours and admission date within 30days following previous discharge date of all-cause hospitalization event, where previous hospitalization was \>=24hours.Time to first occurrence of all-cause hospital re-admission within 30days was analyzed using Cox proportional hazards regression model with treatment group, current ESA use at randomization and region as covariates.Time to the first occurrence was computed as(event date - randomization date)+1. Incidence rate per 100 person years calculated as(100\*number of participants with at least 1event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period., Up to 4.3 person-years for CV follow-up time period|Time to First Occurrence of Adjudicated MACE or Hospitalization for Heart Failure or Thromboembolic Events During CV Events Follow-up Time Period, Time to first occurrence of adjudicated MACE or hospitalization for heart failure or thromboembolic events were analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period., Up to 4.3 person-years for CV follow-up time period|Time to First Occurrence of Adjudicated Hospitalization for Heart Failure During CV Events Follow-up Time Period, Time to first occurrence of adjudicated hospitalization for heart failure was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period., Up to 4.3 person-years for CV follow-up time period|Time to First Occurrence of Adjudicated Thromboembolic Events During CV Events Follow-up Time Period, Time to first occurrence of adjudicated thromboembolic events were analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period., Up to 4.3 person-years for CV follow-up time period|Time to First Occurrence of Confirmed 40% Decline in eGFR During CV Events Follow-up Time Period, Time to first occurrence of confirmed 40% decline in eGFR was analyzed using a Fine \& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use and region as covariates. Time to the first occurrence was computed as (event date minus randomization date)+1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period., Up to 4.3 person-years for CV follow-up time period|Time to First Occurrence of Chronic Dialysis During CV Events Follow-up Time Period, Time to first occurrence of chronic dialysis was analyzed using a Fine \& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use and region as covariates. Chronic dialysis is defined by either initiating dialysis for \>=90 days or not initiating chronic dialysis when dialysis is indicated. Time to the first occurrence was computed as (event date minus randomization date)+1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period., Up to 4.3 person-years for CV follow-up time period|Time to First Occurrence of Kidney Transplant During CV Events Follow-up Time Period, Time to first occurrence of kidney transplant were analyzed using a Fine \& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use and region as covariates. Time to the first occurrence was computed as (event date minus randomization date)+1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period., Up to 4.3 person-years for CV follow-up time period|Change From Baseline in Post-randomization Hgb Levels at Week 52, Blood samples were collected from participants for Hgb measurements. Change from Baseline was defined as post-randomization value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using mixed model repeated measures (MMRM) model fitted from Baseline up to Week 52, excluding values collected during the stabilization period, with factors for treatment, time, current ESA use, region, Baseline Hgb and Baseline Hgb by time and treatment by time interactions., Baseline (Pre-dose on Day 1) and Week 52|Number of Hgb Responders in the Hgb Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52), Mean Hgb during the evaluation period was defined as the mean of all evaluable Hgb values during the evaluation period (Week 28 to Week 52) including any evaluable unscheduled Hgb values that were taken during this time period. Hgb responders were defined as participants with a mean Hgb during the evaluation period that falls within the Hgb analysis range of 10-11.5 g/dL., Week 28 to Week 52|Percentage of Time With Hgb in the Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52): Non-inferiority Analysis, Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time in the analysis range during evaluation period is calculated as time in range during the evaluation period / \[Earlier of (Date of the last evaluable Hgb value, Week 52 visit date) - Later of (Date of the first evaluable Hgb value that between Week 16 and Week 52 inclusive, Week 28 visit date)\]., Week 28 to Week 52|Percentage of Time With Hgb in the Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52): Superiority Analysis, Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time in the analysis range during evaluation period is calculated as time in range during the evaluation period / \[Earlier of (Date of the last evaluable Hgb value, Week 52 visit date) - Later of (Date of the first evaluable Hgb value that between Week 16 and Week 52 inclusive, Week 28 visit date)\]., Week 28 to Week 52|Percentage of Time With Hgb in the Analysis Range (10 to 11.5 Grams/Deciliter) During Maintenance Period (Week 28 to End of Study): Non-inferiority Analysis, Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the maintenance period (Week 28 to end of study), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time in the analysis range during maintenance period is calculated as time in range during the maintenance period / \[Earlier of (Date of the last evaluable Hgb value, End of study date)- Later of (Date of the first evaluable Hgb value that is on or after week 16, Week 28 visit date)\]., Week 28 to end of study (4.3 person-years for follow-up time period)|Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) During Maintenance Period (Week 28 to End of Study): Superiority Analysis, Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the maintenance period (Week 28 to end of study), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time in the analysis range during maintenance period is calculated as time in range during the maintenance period / \[Earlier of (Date of the last evaluable Hgb value, End of study date)- Later of (Date of the first evaluable Hgb value that is on or after week 16, Week 28 visit date)\]., Week 28 to end of study (4.3 person-years for follow-up time period)|Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) at Week 52, SBP, DBP and MAP were measured in a seated position after at least a 5-minutes of rest. MAP is the average (BP) in an individual's arteries during a single cardiac cycle. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using MMRM model with treatment group + time + current ESA use at randomization + region + Baseline value + Baseline value\*time + treatment group\*time, using an unstructured covariance matrix. Data for post-dialysis BP measurements have been presented., Baseline (Week -4) and Week 52|Change From Baseline in SBP, DBP, MAP at End of Treatment, SBP, DBP and MAP were measured in a seated position after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using ANCOVA model with terms for treatment group, current ESA use at randomization, region and Baseline value. Data for post-dialysis BP measurements have been presented., Baseline (Week -4) and 51.1 months|Blood Pressure (BP) Exacerbation Event Rate Per 100 Participant Years, BP exacerbation event (based on post-dialysis) was defined as: SBP \>= 25 millimeter of mercury (mmHg) increased from Baseline or SBP \>=180 mmHg; DBP \>=15 mmHg increased from Baseline or DBP \>=110 mmHg. The BP exacerbation events per 100 participant years was estimated using the negative binomial model with treatment, current ESA use at randomization and region as covariates and the logarithm of time on-treatment as an offset variable. Data for post-dialysis BP measurements have been presented., Day 1 to end of treatment (51.1 months)|Number of Participants With at Least One BP Exacerbation Event During Study, BP exacerbation was defined as: SBP \>= 25 mmHg increased from Baseline or SBP \>=180 mmHg; DBP \>=15 mmHg increased from Baseline or DBP \>=110 mmHg. Number of participants with at least one BP exacerbation event is presented., Day 1 to end of treatment (51.1 months)|Percentage of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria, Percentage of participants permanently stopping randomized treatment due to meeting rescue criteria has been presented., Day 1 to 51.1 months|Change From Baseline in On-treatment Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52, The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). The PCS is an average score derived from 4 domains (physical functioning, role-physical, bodily pain and general health) representing overall physical health. PCS ranges from 0 to 100; higher score represents better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date., Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52|Change From Baseline in On-treatment Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52, The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). MCS is an average score derived from 4 domains (vitality, social functioning, role-emotional and mental health) representing overall mental health. MCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date., Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52|Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52, The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: bodily pain (b pain), general health (GH), mental health (MH), role-emotional (RE) (role limitations caused by emotional problems), role-physical (RP) (role limitations caused by physical problems), social functioning (SF), physical functioning and vitality. Each domain is scored from 0 (poorer health) to 100 (better health). Each domain score ranges from 0 to 100, higher score indicates a better health state and better functioning. Change from Baseline (BL) was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date., Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52|Change From Baseline in On-treatment Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52, The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Vitality score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date., Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52|Change From Baseline in On-treatment Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52, The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Physical functioning score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date., Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52|Change From Baseline in On-treatment Health Utility EuroQol 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire Score at Week 52, EQ-5D-5L is self-assessment questionnaire, consisting of 5 items covering 5 dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression). Each dimension is measured by 5-point Likert scale (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Each of these 5 figure health states were converted to a single index score by applying country-specific value set formula that attaches weights to dimensions and levels. Range for EQ-5D-5L index score is -0.594 (worst health) to 1 (full health state). Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was latest non-missing pre-dose assessment on or before randomization date., Baseline (Pre-dose on Day 1) and Week 52|Change From Baseline in On-treatment EQ Visual Analogue Scale (EQ-VAS) at Week 52, The EQ VAS records the respondent's self-rated health on a vertical VAS, ranging from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date., Baseline (Pre-dose on Day 1) and Week 52|Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52, CKD-AQ is 21-item patient reported outcome measure assessing symptoms and symptom impact in participants with anemia associated with CKD. It had 3 domains: 1.Tired/Low Energy (LE)/Weak scale consisting of 10 items; 2.Chest Pain (CP)/Shortness of Breath (SOB) scale consisting of 4 items; and 3.Cognitive (Cog) scale consisting of 3 items. The 4 CKD-AQ single items are: shortness of breath, no activity; severity-short breath (S-SB), resting; difficulty standing (diff. std.)for long time (LT) and difficulty sleeping (diff sleep). Single-item were recorded based on a 0-100 scoring with 0=worst possible and 100=best possible score. Three domains scores were calculated as average of items in each domain and ranged from 0-100 where 0=worst possible and 100=best possible score. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date., Baseline (Day 1) and Weeks 8, 12, 28, 52|Change From Baseline in On-treatment Patient Global Impression of Severity (PGI-S) at Weeks 8, 12, 28, 52, The PGI-S is a 1-item questionnaire designed to assess participant's impression of disease severity on a 5-point disease severity scale (0=absent, 1=mild, 2=moderate, 3=severe, or 4=very severe). A higher score indicated more disease severity. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date., Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52|Change From Baseline in Post-randomization Estimated Glomerular Filtration Rate (eGFR) at Week 52, Blood samples were collected to analyze estimated glomerular filtration rate. Change from Baseline was calculated as post-Baseline visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date., Baseline (Pre-dose on Day 1) and Week 52 |
| Sponsor/Collaborators: | Sponsor: GlaxoSmithKline |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 3872 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2016-09-27 |
| Completion Date: | 2021-04-19 |
| Results First Posted: | 2022-04-14 |
| Last Update Posted: | 2024-04-02 |
| Locations: | GSK Investigational Site, Andalusia, Alabama, 36420, United States|GSK Investigational Site, Birmingham, Alabama, 35249, United States|GSK Investigational Site, Huntsville, Alabama, 35805, United States|GSK Investigational Site, Glendale, Arizona, 85305, United States|GSK Investigational Site, Mesa, Arizona, 85202, United States|GSK Investigational Site, Phoenix, Arizona, 85016, United States|GSK Investigational Site, Phoenix, Arizona, 85027, United States|GSK Investigational Site, Scottsdale, Arizona, 48201, United States|GSK Investigational Site, Tucson, Arizona, 85745, United States|GSK Investigational Site, Azusa, California, 91702, United States|GSK Investigational Site, Bakersfield, California, 93308, United States|GSK Investigational Site, Bakersfield, California, 93309, United States|GSK Investigational Site, Chula Vista, California, 91910, United States|GSK Investigational Site, Cudahy, California, 90201, United States|GSK Investigational Site, El Centro, California, 92243, United States|GSK Investigational Site, Escondido, California, 92025, United States|GSK Investigational Site, Glendale, California, 91204, United States|GSK Investigational Site, Granada Hills, California, 91344, United States|GSK Investigational Site, La Mesa, California, 91942, United States|GSK Investigational Site, La Palma, California, 90623, United States|GSK Investigational Site, Long Beach, California, 90806, United States|GSK Investigational Site, Los Angeles, California, 90022, United States|GSK Investigational Site, Los Angeles, California, 90095, United States|GSK Investigational Site, Montebello, California, 90640, United States|GSK Investigational Site, National City, California, 91950, United States|GSK Investigational Site, Riverside, California, 92505, United States|GSK Investigational Site, San Diego, California, 92103, United States|GSK Investigational Site, San Diego, California, 92111, United States|GSK Investigational Site, San Luis Obispo, California, 93405, United States|GSK Investigational Site, Simi Valley, California, 93065, United States|GSK Investigational Site, Tarzana, California, 91356, United States|GSK Investigational Site, Whittier, California, 90602, United States|GSK Investigational Site, Middlebury, Connecticut, 06762, United States|GSK Investigational Site, Washington, District of Columbia, 20037, United States|GSK Investigational Site, Aventura, Florida, 33180, United States|GSK Investigational Site, Boca Raton, Florida, 33431, United States|GSK Investigational Site, Coral Gables, Florida, 33134, United States|GSK Investigational Site, Cutler Bay, Florida, 33189, United States|GSK Investigational Site, Doral, Florida, 33122, United States|GSK Investigational Site, Fort Lauderdale, Florida, 33308, United States|GSK Investigational Site, Homestead, Florida, 33033, United States|GSK Investigational Site, Hudson, Florida, 34667, United States|GSK Investigational Site, Jacksonville, Florida, 32224, United States|GSK Investigational Site, Jacksonville, Florida, 32256, United States|GSK Investigational Site, Lauderdale Lakes, Florida, 33313, United States|GSK Investigational Site, Miami Gardens, Florida, 33169, United States|GSK Investigational Site, Miami Lakes, Florida, 33014, United States|GSK Investigational Site, Miami, Florida, 33126, United States|GSK Investigational Site, Miami, Florida, 33143, United States|GSK Investigational Site, Miami, Florida, 33145, United States|GSK Investigational Site, Miami, Florida, 33147, United States|GSK Investigational Site, Miami, Florida, 33150, United States|GSK Investigational Site, Miami, Florida, 33155, United States|GSK Investigational Site, Miami, Florida, 33156, United States|GSK Investigational Site, Miami, Florida, 33165, United States|GSK Investigational Site, Miami, Florida, 33169, United States|GSK Investigational Site, Miami, Florida, 33173, United States|GSK Investigational Site, Ocala, Florida, 34471, United States|GSK Investigational Site, Orlando, Florida, 32810, United States|GSK Investigational Site, Pembroke Pines, Florida, 33028, United States|GSK Investigational Site, Port Charlotte, Florida, 33952, United States|GSK Investigational Site, South Miami, Florida, 33143, United States|GSK Investigational Site, Tampa, Florida, 33612, United States|GSK Investigational Site, Temple Terrace, Florida, 33637, United States|GSK Investigational Site, Atlanta, Georgia, 30342, United States|GSK Investigational Site, Augusta, Georgia, 30904, United States|GSK Investigational Site, Augusta, Georgia, 30909, United States|GSK Investigational Site, Augusta, Georgia, 30912, United States|GSK Investigational Site, Columbus, Georgia, 31904, United States|GSK Investigational Site, Nampa, Idaho, 83687, United States|GSK Investigational Site, Chicago, Illinois, 60611, United States|GSK Investigational Site, Chicago, Illinois, 60643, United States|GSK Investigational Site, Crystal Lake, Illinois, 60014, United States|GSK Investigational Site, Mount Prospect, Illinois, 60056, United States|GSK Investigational Site, Quincy, Illinois, 62301, United States|GSK Investigational Site, Springfield, Illinois, 62702, United States|GSK Investigational Site, Fort Wayne, Indiana, 46845, United States|GSK Investigational Site, Jeffersonville, Indiana, 47130, United States|GSK Investigational Site, Michigan City, Indiana, 46360, United States|GSK Investigational Site, Des Moines, Iowa, 50309, United States|GSK Investigational Site, Iowa City, Iowa, 52242, United States|GSK Investigational Site, Hutchinson, Kansas, 67502, United States|GSK Investigational Site, Wichita, Kansas, 67214, United States|GSK Investigational Site, Louisville, Kentucky, 40202, United States|GSK Investigational Site, Baton Rouge, Louisiana, 70808, United States|GSK Investigational Site, Baton Rouge, Louisiana, 70836, United States|GSK Investigational Site, Metairie, Louisiana, 70006, United States|GSK Investigational Site, Baltimore, Maryland, 21287, United States|GSK Investigational Site, Potomac, Maryland, 20854, United States|GSK Investigational Site, Takoma Park, Maryland, 20912-6385, United States|GSK Investigational Site, Boston, Massachusetts, 02114, United States|GSK Investigational Site, Detroit, Michigan, 48202, United States|GSK Investigational Site, Kalamazoo, Michigan, 49007, United States|GSK Investigational Site, Pontiac, Michigan, 48341, United States|GSK Investigational Site, Minneapolis, Minnesota, 55414, United States|GSK Investigational Site, Jackson, Mississippi, 39216, United States|GSK Investigational Site, Tupelo, Mississippi, 38801, United States|GSK Investigational Site, Saint Louis, Missouri, 63106, United States|GSK Investigational Site, Saint Louis, Missouri, 63110, United States|GSK Investigational Site, North Platte, Nebraska, 69101, United States|GSK Investigational Site, Las Vegas, Nevada, 89106, United States|GSK Investigational Site, Bronx, New York, 10461, United States|GSK Investigational Site, Bronx, New York, 10467, United States|GSK Investigational Site, Brooklyn, New York, 11203, United States|GSK Investigational Site, Buffalo, New York, 14215, United States|GSK Investigational Site, Flushing, New York, 11355, United States|GSK Investigational Site, Laurelton, New York, 11413, United States|GSK Investigational Site, New York, New York, 10021, United States|GSK Investigational Site, New York, New York, 10029, United States|GSK Investigational Site, Ridgewood, New York, 11385, United States|GSK Investigational Site, Yonkers, New York, 10704, United States|GSK Investigational Site, Charlotte, North Carolina, 28204, United States|GSK Investigational Site, Raleigh, North Carolina, 27609, United States|GSK Investigational Site, Rocky Mount, North Carolina, 27804, United States|GSK Investigational Site, Wilmington, North Carolina, 28401, United States|GSK Investigational Site, Winston-Salem, North Carolina, 27103, United States|GSK Investigational Site, Grand Forks, North Dakota, 58201, United States|GSK Investigational Site, Canton, Ohio, 15212, United States|GSK Investigational Site, Cincinnati, Ohio, 45206, United States|GSK Investigational Site, Cincinnati, Ohio, 45220, United States|GSK Investigational Site, Mentor, Ohio, 44060, United States|GSK Investigational Site, Lawton, Oklahoma, 73505, United States|GSK Investigational Site, Portland, Oregon, 97210, United States|GSK Investigational Site, Roseburg, Oregon, 97471, United States|GSK Investigational Site, Bethlehem, Pennsylvania, 18017, United States|GSK Investigational Site, Doylestown, Pennsylvania, 18901, United States|GSK Investigational Site, Lancaster, Pennsylvania, 17601, United States|GSK Investigational Site, Upland, Pennsylvania, 19013, United States|GSK Investigational Site, Wyomissing, Pennsylvania, 19610, United States|GSK Investigational Site, Anderson, South Carolina, 29621, United States|GSK Investigational Site, Charleston, South Carolina, 29425, United States|GSK Investigational Site, Columbia, South Carolina, 29209, United States|GSK Investigational Site, Sumter, South Carolina, 29150, United States|GSK Investigational Site, Cordova, Tennessee, 38018, United States|GSK Investigational Site, Knoxville, Tennessee, 37923, United States|GSK Investigational Site, Memphis, Tennessee, 38163, United States|GSK Investigational Site, Nashville, Tennessee, 37205, United States|GSK Investigational Site, Arlington, Texas, 76002, United States|GSK Investigational Site, Austin, Texas, 78751, United States|GSK Investigational Site, Austin, Texas, 78758, United States|GSK Investigational Site, Corpus Christi, Texas, 78404, United States|GSK Investigational Site, Corsicana, Texas, 75110, United States|GSK Investigational Site, Dallas, Texas, 75237, United States|GSK Investigational Site, Dallas, Texas, 75246, United States|GSK Investigational Site, Houston, Texas, 77004, United States|GSK Investigational Site, Houston, Texas, 77043, United States|GSK Investigational Site, Houston, Texas, 77084, United States|GSK Investigational Site, Houston, Texas, 77099, United States|GSK Investigational Site, Lufkin, Texas, 75904, United States|GSK Investigational Site, McAllen, Texas, 78503, United States|GSK Investigational Site, San Antonio, Texas, 78202, United States|GSK Investigational Site, San Antonio, Texas, 78212, United States|GSK Investigational Site, San Antonio, Texas, 78229, United States|GSK Investigational Site, San Antonio, Texas, 78258, United States|GSK Investigational Site, Temple, Texas, 76508, United States|GSK Investigational Site, Waxahachie, Texas, 75165, United States|GSK Investigational Site, Alexandria, Virginia, 22304, United States|GSK Investigational Site, Fairfax, Virginia, 22033, United States|GSK Investigational Site, Hampton, Virginia, 23666, United States|GSK Investigational Site, Salem, Virginia, 24153, United States|GSK Investigational Site, Bluefield, West Virginia, 24701, United States|GSK Investigational Site, Ciudad Evita, Buenos Aires, B1778IFA, Argentina|GSK Investigational Site, Coronel Suarez, Buenos Aires, 7540, Argentina|GSK Investigational Site, Junín, Buenos Aires, B6000GMA, Argentina|GSK Investigational Site, Mar del Plata, Buenos Aires, 7600, Argentina|GSK Investigational Site, Pergamino, Buenos Aires, B2700CPM, Argentina|GSK Investigational Site, Cordoba, Córdova, 5000, Argentina|GSK Investigational Site, Córdoba, Córdova, 5000, Argentina|GSK Investigational Site, Córdoba, Córdova, X5016KEH, Argentina|GSK Investigational Site, Buenos Aires, 1425, Argentina|GSK Investigational Site, Buenos Aires, C1181ACH, Argentina|GSK Investigational Site, Buenos Aires, CP1431FWO, Argentina|GSK Investigational Site, Corrientes, W3400AMZ, Argentina|GSK Investigational Site, Formosa, P3600LLD, Argentina|GSK Investigational Site, La Plata, B1902COS, Argentina|GSK Investigational Site, Mendoza, M5500AFA, Argentina|GSK Investigational Site, Moron, B1708DPO, Argentina|GSK Investigational Site, San Miguel de Tucumán, T4000AHL, Argentina|GSK Investigational Site, Garran, Australian Capital Territory, 2606, Australia|GSK Investigational Site, Concord, New South Wales, 2139, Australia|GSK Investigational Site, Gosford, New South Wales, 2250, Australia|GSK Investigational Site, Kingswood, New South Wales, 2747, Australia|GSK Investigational Site, Kogarah, New South Wales, 2217, Australia|GSK Investigational Site, Randwick, New South Wales, 2031, Australia|GSK Investigational Site, St Leonards, New South Wales, 2065, Australia|GSK Investigational Site, Wollongong, New South Wales, 2500, Australia|GSK Investigational Site, Nambour, Queensland, 4560, Australia|GSK Investigational Site, Melbourne, Victoria, 3004, Australia|GSK Investigational Site, Reservoir, Victoria, 3073, Australia|GSK Investigational Site, St Albans, Victoria, 3021, Australia|GSK Investigational Site, Nedlands, Western Australia, 6009, Australia|GSK Investigational Site, Liverpool, 2107, Australia|GSK Investigational Site, Aalst, 9300, Belgium|GSK Investigational Site, Baudour, 7331, Belgium|GSK Investigational Site, Brugge, 8310, Belgium|GSK Investigational Site, Brussels, 1200, Belgium|GSK Investigational Site, Ieper, 8900, Belgium|GSK Investigational Site, Leuven, 3000, Belgium|GSK Investigational Site, Liège, 4000, Belgium|GSK Investigational Site, Roeselare, 8800, Belgium|GSK Investigational Site, Ronse, 9600, Belgium|GSK Investigational Site, Sint-Niklaas, 9100, Belgium|GSK Investigational Site, Salvador, Bahia, 40415-065, Brazil|GSK Investigational Site, Curitiba, Paraná, 80440-020, Brazil|GSK Investigational Site, Curitiba, Paraná, 80730-150, Brazil|GSK Investigational Site, Curitiba, Paraná, CEP 80230-130, Brazil|GSK Investigational Site, Passo Fundo, Rio Grande Do Sul, 99010-080, Brazil|GSK Investigational Site, Porto Alegre, Rio Grande Do Sul, 90035-074, Brazil|GSK Investigational Site, Porto Alegre, Rio Grande Do Sul, 90035-903, Brazil|GSK Investigational Site, Porto Alegre, Rio Grande Do Sul, 90610-000, Brazil|GSK Investigational Site, Sao Jose do Rio Preto, São Paulo, 15090-000, Brazil|GSK Investigational Site, Votuporanga, São Paulo, 15500-003, Brazil|GSK Investigational Site, Belo Horizonte, 30150-320, Brazil|GSK Investigational Site, Brasilia, 70840-901, Brazil|GSK Investigational Site, Feira de Santana, 44001-465, Brazil|GSK Investigational Site, Joinville, 89201-010, Brazil|GSK Investigational Site, Juiz De Fora, 36036-330, Brazil|GSK Investigational Site, Sao Paulo, ?01323-001, Brazil|GSK Investigational Site, São Paulo, 01323903, Brazil|GSK Investigational Site, São Paulo, 04039-000, Brazil|GSK Investigational Site, São Paulo, ?04005-000, Brazil|GSK Investigational Site, São Paulo, ?08270-070, Brazil|GSK Investigational Site, Blagoevgrad, 2700, Bulgaria|GSK Investigational Site, Burgas, 8000, Bulgaria|GSK Investigational Site, Dobrich, 9300, Bulgaria|GSK Investigational Site, Gabrovo, 5300, Bulgaria|GSK Investigational Site, Lom, 3600, Bulgaria|GSK Investigational Site, Pazardzhik, 4400, Bulgaria|GSK Investigational Site, Plovdiv, 4000, Bulgaria|GSK Investigational Site, Sliven, 8800, Bulgaria|GSK Investigational Site, Smolyan, 4700, Bulgaria|GSK Investigational Site, Sofia, 1233, Bulgaria|GSK Investigational Site, Sofia, 1709, Bulgaria|GSK Investigational Site, Stara Zagora, 6000, Bulgaria|GSK Investigational Site, Varna, 9000, Bulgaria|GSK Investigational Site, Veliko Tarnovo, 5000, Bulgaria|GSK Investigational Site, Edmonton, Alberta, T6G 2B7, Canada|GSK Investigational Site, Halifax, Nova Scotia, B3H 1V8, Canada|GSK Investigational Site, Brampton, Ontario, L6T 0G1, Canada|GSK Investigational Site, London, Ontario, N6A 5A5, Canada|GSK Investigational Site, Mississauga, Ontario, L4V 1P1, Canada|GSK Investigational Site, Mississauga, Ontario, L5M 2V8, Canada|GSK Investigational Site, Toronto, Ontario, M4C 5T2, Canada|GSK Investigational Site, Greenfield Park, Quebec, J4V 2H1, Canada|GSK Investigational Site, Montreal, Quebec, H3G 1A4, Canada|GSK Investigational Site, Quebec, G1R 2J6, Canada|GSK Investigational Site, Barranquilla, 760002, Colombia|GSK Investigational Site, Bogotá, 111711, Colombia|GSK Investigational Site, Cali, 760007, Colombia|GSK Investigational Site, Floridablanca, 681001, Colombia|GSK Investigational Site, Medellin, 050012, Colombia|GSK Investigational Site, Beroun, 26601, Czechia|GSK Investigational Site, Cesky Krumlov, 38127, Czechia|GSK Investigational Site, Ivancice, 664 95, Czechia|GSK Investigational Site, Jilemnice, 514 01, Czechia|GSK Investigational Site, Marianske Lazne, 353 01, Czechia|GSK Investigational Site, Novy Jicin, 74101, Czechia|GSK Investigational Site, Pardubice, 53203, Czechia|GSK Investigational Site, Praha 2, 128 08, Czechia|GSK Investigational Site, Praha 4, 140 21, Czechia|GSK Investigational Site, Sokolov, 356 01, Czechia|GSK Investigational Site, Aalborg, DK-9000, Denmark|GSK Investigational Site, Holstebro, 7500, Denmark|GSK Investigational Site, Kolding, 6000, Denmark|GSK Investigational Site, Odense C, 5000, Denmark|GSK Investigational Site, Jämejala Village, 71024, Estonia|GSK Investigational Site, Tallinn, EE-13419, Estonia|GSK Investigational Site, Tartu, 50501, Estonia|GSK Investigational Site, Annonay, 07103, France|GSK Investigational Site, Boulogne Billancourt, 92100, France|GSK Investigational Site, Caen Cedex 9, 14033, France|GSK Investigational Site, Clermont-Ferrand, 63000, France|GSK Investigational Site, Lyon, 69003, France|GSK Investigational Site, Montpellier, 34295, France|GSK Investigational Site, Mulhouse, 68100, France|GSK Investigational Site, Poitiers, 86021, France|GSK Investigational Site, Saint-Ouen, 93400, France|GSK Investigational Site, Mannheim, Baden-Wuerttemberg, 68167, Germany|GSK Investigational Site, Muenchen, Bayern, 81675, Germany|GSK Investigational Site, Cloppenburg, Niedersachsen, 49661, Germany|GSK Investigational Site, Duesseldorf, Nordrhein-Westfalen, 40210, Germany|GSK Investigational Site, Muenster, Nordrhein-Westfalen, 48149, Germany|GSK Investigational Site, Kaiserslautern, Rheinland-Pfalz, 67655, Germany|GSK Investigational Site, Leipzig, Sachsen, 04129, Germany|GSK Investigational Site, Koeln, 50937, Germany|GSK Investigational Site, Wiesbaden, 65191, Germany|GSK Investigational Site, Alexandroupolis, 68100, Greece|GSK Investigational Site, Arta, 471 00, Greece|GSK Investigational Site, Athens, 115 26, Greece|GSK Investigational Site, Athens, 11526, Greece|GSK Investigational Site, Athens, 11527, Greece|GSK Investigational Site, Athens, 12462, Greece|GSK Investigational Site, Efkarpia, 564 29, Greece|GSK Investigational Site, Heraklion-Crete, 71110, Greece|GSK Investigational Site, Ioannina, 45001, Greece|GSK Investigational Site, Ioannina, 45500, Greece|GSK Investigational Site, Komotini, 69100, Greece|GSK Investigational Site, Larissa, 41100, Greece|GSK Investigational Site, Melissia, 15127, Greece|GSK Investigational Site, Patras, 26500, Greece|GSK Investigational Site, Thessaloniki, 546 42, Greece|GSK Investigational Site, Thessaloniki, 54636, Greece|GSK Investigational Site, Thessaloniki, 551 34, Greece|GSK Investigational Site, Thessaloniki, 57001, Greece|GSK Investigational Site, Thessaloniki, 57010, Greece|GSK Investigational Site, Hong Kong, Hong Kong|GSK Investigational Site, Lai Chi kok, Hong Kong|GSK Investigational Site, New Territories, Hong Kong|GSK Investigational Site, Tsuen Wan, Hong Kong|GSK Investigational Site, Baja, 6500, Hungary|GSK Investigational Site, Balatonfured, 8230, Hungary|GSK Investigational Site, Esztergom, 2500, Hungary|GSK Investigational Site, Kecskemét, 6000, Hungary|GSK Investigational Site, Miskolc, 3526, Hungary|GSK Investigational Site, Pecs, 7623, Hungary|GSK Investigational Site, Salgótarján, 3100, Hungary|GSK Investigational Site, Szigetvar, 7900, Hungary|GSK Investigational Site, Ahmedabad, 380054, India|GSK Investigational Site, Ahmedabad, 380059, India|GSK Investigational Site, Bangalore, 560054, India|GSK Investigational Site, Bangalore, 560055, India|GSK Investigational Site, Calicut, 673008, India|GSK Investigational Site, Chandigarh, 160012, India|GSK Investigational Site, Chennai, Tamil Nadu, 600 006, India|GSK Investigational Site, Chennai, 600037, India|GSK Investigational Site, Delhi, 110076, India|GSK Investigational Site, Ghaziabad, 201012, India|GSK Investigational Site, Gurgaon, 122001, India|GSK Investigational Site, Hyderabad, 500012, India|GSK Investigational Site, Hyderabad, 500034, India|GSK Investigational Site, Jaipur, 302004, India|GSK Investigational Site, Jaipur, 302018, India|GSK Investigational Site, Lucknow, 226014, India|GSK Investigational Site, Manipal, 576104, India|GSK Investigational Site, Mumbai, 400008, India|GSK Investigational Site, Mumbai, 400016, India|GSK Investigational Site, Nadiad, 387001, India|GSK Investigational Site, Nagpur, 440010, India|GSK Investigational Site, New Delhi, 110002, India|GSK Investigational Site, New Delhi, 110017, India|GSK Investigational Site, New Delhi, 110025, India|GSK Investigational Site, New Delhi, 110060, India|GSK Investigational Site, Pune, 411004, India|GSK Investigational Site, Pune, 411033, India|GSK Investigational Site, Secunderabad, 560020, India|GSK Investigational Site, Trivandrum, 695011, India|GSK Investigational Site, Ashkelon, 78278, Israel|GSK Investigational Site, Hadera, PO Box 169, Israel|GSK Investigational Site, Haifa, 31096, Israel|GSK Investigational Site, Kfar Saba, 44281, Israel|GSK Investigational Site, Nahariya, 22100, Israel|GSK Investigational Site, Nazareth, 16100, Israel|GSK Investigational Site, Poriya, 15208, Israel|GSK Investigational Site, Zerifin, 70300, Israel|GSK Investigational Site, Catanzaro, Calabria, 88100, Italy|GSK Investigational Site, Napoli, Campania, 80131, Italy|GSK Investigational Site, Piacenza, Emilia-Romagna, 29100, Italy|GSK Investigational Site, Reggio Emilia, Emilia-Romagna, 42123, Italy|GSK Investigational Site, Genova, Liguria, 16132, Italy|GSK Investigational Site, Lecco, Lombardia, 23900, Italy|GSK Investigational Site, Milano, Lombardia, 20132, Italy|GSK Investigational Site, Pavia, Lombardia, 27100, Italy|GSK Investigational Site, Torino, Piemonte, 10154, Italy|GSK Investigational Site, Foggia, Puglia, 71100, Italy|GSK Investigational Site, Cagliari, Sardegna, ?09100, Italy|GSK Investigational Site, Imola, 40026, Italy|GSK Investigational Site, Mestre, 30122, Italy|GSK Investigational Site, Anyang-Si, Gyeonggi-do, 14068, Korea, Republic of|GSK Investigational Site, Bucheon, 420-767, Korea, Republic of|GSK Investigational Site, Busan, 48108, Korea, Republic of|GSK Investigational Site, Daegu, 41931, Korea, Republic of|GSK Investigational Site, Daegu, 41944, Korea, Republic of|GSK Investigational Site, Daejeon, 301-721, Korea, Republic of|GSK Investigational Site, Goyang-si, 10444, Korea, Republic of|GSK Investigational Site, Ilsanseo-gu, Goyang-si,, 10380, Korea, Republic of|GSK Investigational Site, Incheon, 021431, Korea, Republic of|GSK Investigational Site, Incheon, 405-760, Korea, Republic of|GSK Investigational Site, Jeonju-si, 54987, Korea, Republic of|GSK Investigational Site, Seongnam, 13620, Korea, Republic of|GSK Investigational Site, Seoul, 06973, Korea, Republic of|GSK Investigational Site, Seoul, 07061, Korea, Republic of|GSK Investigational Site, Seoul, 08308, Korea, Republic of|GSK Investigational Site, Seoul, 134-727, Korea, Republic of|GSK Investigational Site, Seoul, 135-710, Korea, Republic of|GSK Investigational Site, Seoul, 137-701, Korea, Republic of|GSK Investigational Site, Seoul, 158-710, Korea, Republic of|GSK Investigational Site, Seoul, 3080, Korea, Republic of|GSK Investigational Site, Seoul, ?02447, Korea, Republic of|GSK Investigational Site, Seoul, ?05355, Korea, Republic of|GSK Investigational Site, Suwon, 16499, Korea, Republic of|GSK Investigational Site, Suwon, 442-723, Korea, Republic of|GSK Investigational Site, Uijeongbu-si, 11765, Korea, Republic of|GSK Investigational Site, Wonju-si, 26426, Korea, Republic of|GSK Investigational Site, Alor Setar, 55600, Malaysia|GSK Investigational Site, Ipoh, 30450, Malaysia|GSK Investigational Site, Kuala Lumpur, 50603, Malaysia|GSK Investigational Site, Kuantan, 25100, Malaysia|GSK Investigational Site, Lumut, 32040, Malaysia|GSK Investigational Site, Pahang, 28000, Malaysia|GSK Investigational Site, Penang, 10990, Malaysia|GSK Investigational Site, Saltillo, Coahuila, CP 25230, Mexico|GSK Investigational Site, Torreon, Coahuila, 27000, Mexico|GSK Investigational Site, Durango., Durango, 34000, Mexico|GSK Investigational Site, Ciudad De Mexico, Estado De México, 14080, Mexico|GSK Investigational Site, Leon, Guanajuato, 37530, Mexico|GSK Investigational Site, León, Guanajuato, 37000, Mexico|GSK Investigational Site, Guadalajara., Jalisco, 44600, Mexico|GSK Investigational Site, Guadalajara, Jalisco, 44620, Mexico|GSK Investigational Site, Cuernavaca, Morelos, 62448, Mexico|GSK Investigational Site, Monterrey, Nuevo León, 64000, Mexico|GSK Investigational Site, Queretaro, Querétaro, 76000, Mexico|GSK Investigational Site, Culiacan, Sinaloa, 80200, Mexico|GSK Investigational Site, Culiacan, Sinaloa, 80230, Mexico|GSK Investigational Site, Mazatlán, Sinaloa, 82020, Mexico|GSK Investigational Site, Merida, Yucatán, 97133, Mexico|GSK Investigational Site, Merida, Yucatán, CP 97070, Mexico|GSK Investigational Site, Aguascalientes, 20230, Mexico|GSK Investigational Site, Chihuahua, 31203, Mexico|GSK Investigational Site, Chihuahua, 31217, Mexico|GSK Investigational Site, Ciudad De México, 06100, Mexico|GSK Investigational Site, Ciudad De México, ?03800, Mexico|GSK Investigational Site, Culiacan, 80030, Mexico|GSK Investigational Site, Tlalnepantla De Baz, 54055, Mexico|GSK Investigational Site, Veracruz, 91020, Mexico|GSK Investigational Site, Zapopan, Jalisco, 45030, Mexico|GSK Investigational Site, Amsterdam, 1081 HV, Netherlands|GSK Investigational Site, Deventer, 7416 SE, Netherlands|GSK Investigational Site, Rotterdam, 3079 DZ, Netherlands|GSK Investigational Site, Dunedin, 9016, New Zealand|GSK Investigational Site, Hamilton, 2001, New Zealand|GSK Investigational Site, Hastings, 4156, New Zealand|GSK Investigational Site, Otahuhu, 1640, New Zealand|GSK Investigational Site, Takapuna, Auckland, ?0740, New Zealand|GSK Investigational Site, Baguio City, Benguet, 2600, Philippines|GSK Investigational Site, Cebu City, 6000, Philippines|GSK Investigational Site, Dasmarinas, 4114, Philippines|GSK Investigational Site, Iloilo City, 5000, Philippines|GSK Investigational Site, Manila, 1000, Philippines|GSK Investigational Site, Pasig, 1605, Philippines|GSK Investigational Site, Quezon City, 1100, Philippines|GSK Investigational Site, San Juan, 1500, Philippines|GSK Investigational Site, Sto Tomas, 4234, Philippines|GSK Investigational Site, Bialystok, 15-540, Poland|GSK Investigational Site, Brzeg, 49301, Poland|GSK Investigational Site, Gdansk, 80-952, Poland|GSK Investigational Site, Katowice, 40-027, Poland|GSK Investigational Site, Kielce, 25-736, Poland|GSK Investigational Site, Kolobrzeg, 78-100, Poland|GSK Investigational Site, Lodz, 92-213, Poland|GSK Investigational Site, Radom, 26-610, Poland|GSK Investigational Site, Szczecin, 70-111, Poland|GSK Investigational Site, Zyrardow, 96-300, Poland|GSK Investigational Site, Amadora, 2720-276, Portugal|GSK Investigational Site, Aveiro, 3814-501, Portugal|GSK Investigational Site, Covilhã, 6200-000, Portugal|GSK Investigational Site, Lisboa, 1069-166, Portugal|GSK Investigational Site, Lisboa, 1250-189, Portugal|GSK Investigational Site, Lisboa, 1400-195, Portugal|GSK Investigational Site, Torres Novas, 2350-754, Portugal|GSK Investigational Site, Bucharest, 022328, Romania|GSK Investigational Site, Bucharest, ?022328, Romania|GSK Investigational Site, Bucharest, ?042122, Romania|GSK Investigational Site, Bucuresti, 022328, Romania|GSK Investigational Site, Constanta, 900591, Romania|GSK Investigational Site, Oradea, 410469, Romania|GSK Investigational Site, Timisoara, 300723, Romania|GSK Investigational Site, Irkutsk, 664049, Russian Federation|GSK Investigational Site, Kemerovo, 650060, Russian Federation|GSK Investigational Site, Krasnodar, 350029, Russian Federation|GSK Investigational Site, Moscow, 119121, Russian Federation|GSK Investigational Site, Mytischi, 141009, Russian Federation|GSK Investigational Site, Omsk, 644112, Russian Federation|GSK Investigational Site, Podolsk, 142110, Russian Federation|GSK Investigational Site, Ryazan, 390026, Russian Federation|GSK Investigational Site, Smolensk, 214006, Russian Federation|GSK Investigational Site, St. Petersburg, 194104, Russian Federation|GSK Investigational Site, St. Petersburg, 196247, Russian Federation|GSK Investigational Site, Ulyanovsk, 432063, Russian Federation|GSK Investigational Site, Volzhsky, 404120, Russian Federation|GSK Investigational Site, Yaroslavl, 150062, Russian Federation|GSK Investigational Site, Singapore, 119074, Singapore|GSK Investigational Site, Singapore, 169608, Singapore|GSK Investigational Site, Singapore, 308433, Singapore|GSK Investigational Site, Singapore, 768828, Singapore|GSK Investigational Site, Port Elizabeth, Eastern Cape, 6001, South Africa|GSK Investigational Site, Cape Town., 7925, South Africa|GSK Investigational Site, Cape Town, 7500, South Africa|GSK Investigational Site, Somerset West, 7130, South Africa|GSK Investigational Site, Majadahonda, Madrid, 28222, Spain|GSK Investigational Site, Badalona, 08916, Spain|GSK Investigational Site, Barcelona, 08003, Spain|GSK Investigational Site, Barcelona, 08011, Spain|GSK Investigational Site, Barcelona, 08025, Spain|GSK Investigational Site, Barcelona, 08035, Spain|GSK Investigational Site, Burela, 27880, Spain|GSK Investigational Site, Caceres, 10003, Spain|GSK Investigational Site, Ciudad Real, 13002, Spain|GSK Investigational Site, Girona, 17007, Spain|GSK Investigational Site, Guadalajara, 19002, Spain|GSK Investigational Site, L'Hospitalet de Llobregat, 08907, Spain|GSK Investigational Site, Mollet del Valles, ?08100, Spain|GSK Investigational Site, Santiago de Compostela, 15706, Spain|GSK Investigational Site, Sevilla, 41071, Spain|GSK Investigational Site, Stockholm, SE-141 86, Sweden|GSK Investigational Site, Uppsala, SE-75185, Sweden|GSK Investigational Site, Örebro, SE-701 85, Sweden|GSK Investigational Site, Kaohsiung, 807, Taiwan|GSK Investigational Site, Kaohsiung, 833, Taiwan|GSK Investigational Site, Keelung, 204, Taiwan|GSK Investigational Site, New Taipei, 220, Taiwan|GSK Investigational Site, Tainan, 704, Taiwan|GSK Investigational Site, Taipei, 10002, Taiwan|GSK Investigational Site, Taipei, 104, Taiwan|GSK Investigational Site, Taipei, 112, Taiwan|GSK Investigational Site, Taipei, 116, Taiwan|GSK Investigational Site, Taoyuan Hsien, 333, Taiwan|GSK Investigational Site, Bangkoknoi, 10700, Thailand|GSK Investigational Site, Bangkok, 10330, Thailand|GSK Investigational Site, Bangkok, 10400, Thailand|GSK Investigational Site, Bangkok, 11000, Thailand|GSK Investigational Site, Chiang Mai, 50200, Thailand|GSK Investigational Site, Khon Kaen, 40002, Thailand|GSK Investigational Site, Pathumthani, 12120, Thailand|GSK Investigational Site, Adana, ?01330, Turkey|GSK Investigational Site, Ankara, ?06100, Turkey|GSK Investigational Site, Antalya, ?07059, Turkey|GSK Investigational Site, Edirne, 22030, Turkey|GSK Investigational Site, Eskisehir, 26480, Turkey|GSK Investigational Site, Istanbul, 34130, Turkey|GSK Investigational Site, Istanbul, 34381, Turkey|GSK Investigational Site, Istanbul, 34899, Turkey|GSK Investigational Site, Kayseri, 38039, Turkey|GSK Investigational Site, Cherkasy, 18009, Ukraine|GSK Investigational Site, Chernihiv, 14029, Ukraine|GSK Investigational Site, Chernivtsi, 58005, Ukraine|GSK Investigational Site, Ivano-Frankivsk, 76008, Ukraine|GSK Investigational Site, Kharkiv, 61039, Ukraine|GSK Investigational Site, Kherson, 73039, Ukraine|GSK Investigational Site, Kiev, ?04107, Ukraine|GSK Investigational Site, Kyiv, 01014, Ukraine|GSK Investigational Site, Kyiv, 04112, Ukraine|GSK Investigational Site, Kyiv, ?01023, Ukraine|GSK Investigational Site, Kyiv, ?04050, Ukraine|GSK Investigational Site, Lutsk, 43000, Ukraine|GSK Investigational Site, Mykolaiv, 54058, Ukraine|GSK Investigational Site, Poltava, 36011, Ukraine|GSK Investigational Site, Ternopil, 46002, Ukraine|GSK Investigational Site, Zaporizhzhia, 69001, Ukraine|GSK Investigational Site, Zaporizhzhia, 69600, Ukraine|GSK Investigational Site, Zhytomyr, 10002, Ukraine|GSK Investigational Site, Stevenage, Hertfordshire, SG1 4AB, United Kingdom|GSK Investigational Site, Preston, Lancashire, PR2 9HT, United Kingdom|GSK Investigational Site, Hampstead, London, NW3 2QG, United Kingdom|GSK Investigational Site, Liverpool, Merseyside, L7 8XP, United Kingdom|GSK Investigational Site, Wolverhampton, West Midlands, WV10 0QP, United Kingdom|GSK Investigational Site, Birmingham, B9 5SS, United Kingdom|GSK Investigational Site, Bristol, BS10 5NB, United Kingdom|GSK Investigational Site, Cambridge, CB2 0QQ, United Kingdom|GSK Investigational Site, Cardiff, CF14 4XW, United Kingdom|GSK Investigational Site, Derby, DE22 3NE, United Kingdom|GSK Investigational Site, Doncaster, DN2 5LT, United Kingdom|GSK Investigational Site, Fife, KY2 5AH, United Kingdom|GSK Investigational Site, Glasgow., G51 4TF, United Kingdom|GSK Investigational Site, Hull, HU3 2JZ, United Kingdom|GSK Investigational Site, Leeds, LS9 7TF, United Kingdom|GSK Investigational Site, London, E1 1BB, United Kingdom|GSK Investigational Site, London, SE5 9RS, United Kingdom|GSK Investigational Site, Manchester, M13 9WL, United Kingdom|GSK Investigational Site, Middlesbrough, TS4 3BW, United Kingdom|GSK Investigational Site, Oxford, OX3 7LE, United Kingdom|GSK Investigational Site, Salford, M6 8HD, United Kingdom|GSK Investigational Site, York, YO31 8HE, United Kingdom|GSK Investigational Site, Ha Noi City, 10000, Vietnam|GSK Investigational Site, Ha Noi, 10000, Vietnam|GSK Investigational Site, Hai Phong, 180000, Vietnam|GSK Investigational Site, Hanoi, 11000, Vietnam|GSK Investigational Site, Ho Chi Minh City, 700000, Vietnam|GSK Investigational Site, Ho Chi Minh, 700000, Vietnam |
| URL: | https://clinicaltrials.gov/show/NCT02876835 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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