| Trial ID: | L1697 |
| Source ID: | NCT02075463
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| Associated Drug: |
Gsk1278863
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| Title: |
Study to Evaluate the Safety and Efficacy of GSK1278863 in Recombinant Human Erythropoietin (rhEPO) Hyporesponsive Hemodialysis-dependent Chronic Kidney Disease Subjects With Anemia
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| Acronym: |
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| Status: |
TERMINATED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT02075463/results
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| Conditions: |
Anemia
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| Interventions: |
DRUG: GSK1278863|DRUG: Placebo
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| Outcome Measures: |
Primary: Percentage of Participants Demonstrating an Increase in Hgb of >=1 g/dL (if Baseline Hgb is <9.5 g/dL), or >=0.5 g/dL (if Baseline Hgb is 9.5-<10 g/dL), or Stay Within Target Range and do Not Drop by >0.5 g/dL (if Baseline Hgb is >= 10 g/dL) at Week 16, Percentage of participants with increased Hgb \>=1 g/dL (if baseline Hgb is \<9.5 g/dL), or \>=0.5 g/dL (if baseline Hgb is 9.5-\<10 g/dL), or within the target range and not dropped by \>0.5 g/dL (if baseline Hgb is \>= 10 g/dL) at Week 16 are presented. Participants who were available at the indicated time point were analyzed, Week 16 | Secondary: Change From Baseline in Hgb Levels at Week 16, Hgb values measured at Week 16 are presented. Change from baseline was calculated as Week 16 minus baseline value . Participants who were available at the indicated time point were analyzed., Week 16|Percentage of Time (Days) Hgb Levels Within, Below and Above Target Range at the Indicated Time Point, The percentage of time in Hgb levels were in target range (10.0 to 11.5 g/dL) between Weeks 12 and 16 for a participant was calculated by adding the total number of days that Hgb is within target range while on treatment during Weeks 12 to 16 and dividing by the total number of days the participant remained on treatment during Weeks 12 to 16 (using Rosendaal linear interpolation method). Similarly, percentage of time above Hgb target range and percentage of time below Hgb target range were calculated. Participants who were available at the indicated time point were analyzed., Week 12 to Week 16|Number of Participants Achieving at Least 1 g/dL Increase in Hgb From Baseline at Week 16, Number of participants achieving at least 1 g/dL increase in Hgb from baseline at Week 16 were presented. Participants who were available at the indicated time point were analyzed., Baseline and Week 16|Number of Participants With Hgb in the Target Range at Week 16, The number of participants with Hgb in the target range of 10.0 to 11.5 g/dL at Week 16 were analyzed. Participants who were available at the indicated time point were analyzed., Week 16|Number of Participants Reaching Pre-defined Hgb Stopping Criteria, The number of participants who reached the Hgb stopping criteria of Hgb concentration \<7.5 g/dL from baseline to Week 16 were presented. Participants who were available at the indicated time point were analyzed., Up to Week 16|Percent Change From Baseline in Hepcidin at Week 16, Hepcidin is a regulator of iron metabolism. Baseline value for hepcidin is the pre-dose value on Day 1. Percent change was calculated as 100 multiplied by \[exponential (log Week 16 value - log Baseline value) minus 1\]. Participants who were available at the indicated time point were analyzed., Baseline (Day 1) and Week 16|Change From Baseline in Ferritin at Week 16, Baseline value for ferritin is the last pre-dose value on Day 1. Change from Baseline in ferritin was calculated as the Week 16 value minus the Baseline value. Participants who were available at the indicated time point were analyzed., Baseline (Day 1) and Week 16|Change From Baseline in Transferrin at Week 16, Baseline value for transferrin is the last pre-dose value on Day 1. Change from Baseline in transferrin was calculated as the Week 16 value minus the Baseline value. Participants who were available at the indicated time point were analyzed., Baseline (Day 1) and Week 16|Percent Change From Baseline in Transferrin Saturation at Week 16, Transferrin saturation is measured in percentage, it is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Baseline value for transferrin saturation is the pre-dose value on Day 1. Percent change is 100 times \[exponential (log Week 16 value minus log Baseline value) -1\]. Participants who were available at the indicated time point were analyzed., Baseline (Day 1) and Week 16|Change From Baseline in Total Iron at Week 16, Baseline value for total iron is the last pre-dose value on Day 1. Change from Baseline in total iron was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points., Baseline (Day 1) and Week 16|Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 16, Total iron-binding capacity is a medical laboratory test that measures the blood's capacity to bind iron with transferrin. Baseline value for total iron binding capacity is the last pre-dose value on Day 1. Change from Baseline in total iron binding capacity was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points., Baseline (Day 1) and Week 16|Reticulocyte Hgb Content (CHr) at Week 16, Data has been presented for only those participants who were available at indicated timepoints, Week 16|Mean Corpuscular Volume (MCV) at Week 16, Data has been presented for only those participants who were available at indicated time points., Week 16|Mean Corpuscular Hemoglobin (MCH) at Week 16, Data has been presented for only those participants who were available at indicated time points., Week 16|Change From Baseline in Hematocrit at Week 16, Hematocrit is the ratio of the volume of red blood cells to the total volume of blood. Baseline value for hematocrit is the pre-dose value on Day 1. Change from Baseline in hematocrit was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points., Baseline (Day 1) and Week 16|Change From Baseline in Red Blood Cell (RBC) at Week 16, Baseline value for RBC (or erythrocytes) is the last pre-dose value on Day 1. Change from Baseline in red blood cells was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points, Baseline (Day 1) and Week 16|Change From Baseline in Reticulocyte Number at Week 16, Baseline value for reticulocyte number is the pre-dose value on Day 1. Change from Baseline in reticulocyte number was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points., Baseline (Day 1) and Week 16|Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF), Blood samples were collected on Day 1 (pre-dose), Week 4 (6-12 hours post-dose, then 1, 2 and 3 hours after first sample), Week 8 (pre-dose), Week 12 (pre-dose and 3 hour post-dose) and Week 16 (pre-dose) for VEGF measurement. The maximum observed percent change from Baseline in VEGF in the subjects was reported. Baseline value for VEGF is the last pre-dose value on Day 1. Percent change was calculated as 100 multiplied by exponential (log observed maximum value minus log Baseline value) minus 1. Participants who were available at the indicated time point were analyzed., Baseline (Day 1) to Week 16|Maximum Observed Change From Baseline in Erythropoietin (EPO), Blood samples were collected on Day 1 (pre-dose), Week 4 (6-12 hours post-dose, then 1, 2 and 3 hours after first sample), Week 8 (pre-dose), Week 12 (pre-dose and 3 hour post-dose) and Week 16 (pre-dose) for EPO measurement. The maximum observed change from baseline in EPO was reported. Baseline value for EPO is the last pre-dose value on Day 1. Change from baseline is calculated as the maximum observed value minus the baseline value. Participants who were available at the indicated time point were analyzed., Baseline (Day 1) to Week 16|Final Dose of GSK1278863, For the first 4 weeks, subjects received 12mg QD of GSK1278863 with dose decrease permitted at Week 2. After 4 weeks of treatment with GSK1278863, need for dose adjustment was evaluated at visits 4, 8 and 12, to maintain hemoglobin within the target range. Target range was defined as: Hgb Criteria of 10.0 to 11.5 g/dL. Data has been presented for only those participants who were available at indicated time points., Up to 16 Weeks|Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points, Blood samples were collected for individual plasma GSK1278863and metabolite (GSK2391220, GSK2499166, GSK2531403, GSK2531400, GSK2531399, and GSK2531398) concentrations measurement on Day (D) 1 (pre-dose \[PrD\]), at Week (W) 4 (6-12, 7-13, 8-14, and 9-15 hour \[hr\] post-dose \[PoD), and at W12 (PrD, 1, 2, and 3 hour PoD). Pharmacokinetic population: All participants from whom a PK sample has been obtained and analyzed., Day 1, Week 4 and Week 12
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| Sponsor/Collaborators: |
Sponsor: GlaxoSmithKline
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE2
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| Enrollment: |
15
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2014-06-01
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| Completion Date: |
2016-03-16
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| Results First Posted: |
2017-06-21
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| Last Update Posted: |
2017-06-21
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| Locations: |
GSK Investigational Site, Azusa, California, 91702, United States|GSK Investigational Site, Glendale, California, 91204, United States|GSK Investigational Site, Los Angeles, California, 90022, United States|GSK Investigational Site, Los Angeles, California, 90025, United States|GSK Investigational Site, Paramount, California, 90723, United States|GSK Investigational Site, San Diego, California, 92115, United States|GSK Investigational Site, Simi Valley, California, 93065, United States|GSK Investigational Site, Middlebury, Connecticut, 06762, United States|GSK Investigational Site, Hollywood, Florida, 33024, United States|GSK Investigational Site, Tampa, Florida, 33609, United States|GSK Investigational Site, Macon, Georgia, 31217, United States|GSK Investigational Site, Southgate, Michigan, 48195, United States|GSK Investigational Site, Saint Ann, Missouri, 63074, United States|GSK Investigational Site, Saint Louis, Missouri, 63110, United States|GSK Investigational Site, Amherst, New York, 14226, United States|GSK Investigational Site, Asheville, North Carolina, 28801, United States|GSK Investigational Site, Bethlehem, Pennsylvania, 18017, United States|GSK Investigational Site, Knoxville, Tennessee, 37923, United States|GSK Investigational Site, Houston, Texas, 77004, United States
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| URL: |
https://clinicaltrials.gov/show/NCT02075463
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