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Clinical Trial Details

Trial ID: L1286
Source ID: NCT02780726
Associated Drug: Roxadustat
Title: A Study of Intermittent Oral Dosing of ASP1517 in Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia
Interventions: DRUG: roxadustat
Outcome Measures: Primary: Hemoglobin (Hb) Response Rate from Week 18 to Week 24, Hb response defined as average Hb within the target range in this outcome, Up to Week 24 | Secondary: Hb Response rate, Hb response is defined as reaching target values for Hb and change of Hb from baseline in this outcome., Up to Week 24|Average Hb levels from week 18 to week 24, Up to week 24|Change from baseline in the average Hb levels of week 18 to week 24, Baseline and up to Week 24|Rate of rise in Hb levels (g/dL/week), Up to Week 4|Proportion of time points with target Hb levels, Up to Week 24|Proportion of participants who achieve the target Hb level at each week, Up to Week 24|Proportion of participants who achieve the lower limit of the target Hb level, Up to Week 24|Time to achieve the lower limit of the target Hb level, Up to Week 24|Change from baseline in Hb level at each week, Baseline and Up to Week 24|Efficacy assessed by hematocrit, Hematocrit will be summarized by ASP1517 low dose Erythropoieses Stimulating Agent (ESA) untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group., Up to Week 24|Efficacy assessed by reticulocytes/ erythrocytes, Reticulocytes/Erythrocytes will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group., Up to Week 24|Efficacy assessed by Iron (Fe), Fe will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group., Up to Week 24|Efficacy assessed by ferritin, Ferritin will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group., Up to Week 24|Efficacy assessed by transferrin, Transferrin will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group., Up to Week 24|Efficacy assessed by total iron binding capacity, Total iron binding capacity will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group., Up to Week 24|Efficacy assessed by soluble transferrin receptor, Soluble transferrin receptor will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group., Up to Week 24|Efficacy assessed by transferrin saturation, Transferrin saturation will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group., Up to Week 24|Efficacy assessed by reticulocyte hemoglobin content, Reticulocyte hemoglobin content will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group., Up to Week 24|Quality of life assessed by SF-36, SF-36: Medical Outcomes Study 36-Item Short-Form Health Survey, Up to Week 24|Quality of life assessed by EQ-5D, EQ-5D: EuroQol 5 Dimension, Up to Week 24|Quality of life assessed by FACT-An, FACT-An: Functional Assessment of Cancer Therapy-Anemia, Up to Week 24|Occurrence of hospitalizations, Up to Week 24|Safety assessed by incidence of adverse events, Up to Week 24|Number of participants with abnormal Vital signs and/or adverse events related to treatment, Up to Week 24|Safety assessed by standard 12-lead electrocardiogram, Up to Week 24|Number of participants with abnormal Laboratory values and/or adverse events related to treatment, Up to Week 24|Plasma concentration of unchanged ASP1517, Up to Week 24
Sponsor/Collaborators: Sponsor: Astellas Pharma Inc | Collaborators: FibroGen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 56
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-06-22
Completion Date: 2017-08-02
Results First Posted:
Last Update Posted: 2024-10-30
Locations: Site JP00002, Aichi, Japan|Site JP00004, Aichi, Japan|Site JP00010, Aichi, Japan|Site JP00013, Aichi, Japan|Site JP00001, Fukuoka, Japan|Site JP00005, Fukuoka, Japan|Site JP00012, Hokkaido, Japan|Site JP00014, Hokkaido, Japan|Site JP00006, Ishikawa, Japan|Site JP00008, Kanagawa, Japan|Site JP00003, Nagano, Japan|SIte JP00015, Okayama, Japan|Site JP00009, Osaka, Japan|Site JP00007, Tokushima, Japan|Site JP00011, Toyama, Japan
URL: https://clinicaltrials.gov/show/NCT02780726