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Clinical Trial Details

Trial ID: L1142
Source ID: NCT02952092
Associated Drug: Roxadustat
Title: A Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Hemodialysis Chronic Kidney Disease Patients With Anemia
Interventions: DRUG: roxadustat|DRUG: Darbepoetin alfa
Outcome Measures: Primary: Change from baseline in the average hemoglobin (Hb), Baseline and Weeks 18 to 24 | Secondary: Average Hb from Week 18 to Week 24, Week 18 to 24|Proportion of participants with the target Hb level from Week 18 to Week 24, Week 18 to 24|Proportion of participants with the target Hb level at each week, Up to Week 24|Change from week 0 in Hb levels to each week, Up to Week 24|Proportion of measurement points with the target Hb level from Week 18 to Week 24, Week 18 to 24|Rate of rise in Hb levels (g/dL/week) from week 0 to at the earliest date of week 4, time of discontinuation, or time of dose adjustment, Up to Week 4|Average hematocrit level, Up to Week 24|Average reticulocyte level, Up to Week 24|Average iron (Fe) level, Up to Week 24|Average ferritin level, Up to Week 24|Average transferrin level, Up to Week 24|Average total iron binding capacity level, Up to Week 24|Average soluble transferrin receptor level, Up to Week 24|Average transferrin saturation level, Up to Week 24|Average reticulocyte hemoglobin content level, 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-5L, EQ-5D-5L: EuroQol 5 Dimension 5-Levels, Up to Week 24|Quality of life assessed by FACT-An, FACT-An: Functional Assessment of Cancer Therapy-Anemia, Up to Week 24|Number of hospitalizations, Up to Week 24|Duration of hospitalizations, Up to Week 24|Plasma concentration of unchanged ASP1517, Up to Week 24|Safety assessed by incidence of adverse events, Up to Week 24|Number of participants with abnormal Laboratory values and/or adverse events related to treatment, Up to Week 24|Number of participants with abnormal Vital signs and/or adverse events related to treatment, Up to Week 24|Number of participants with abnormal 12-lead electrocardiogram (ECG) values, Any clinically significant adverse changes on the ECG will be reported as adverse events., Up to Week 24|Safety assessed by ophthalmological examination: fundoscopy, Up to Week 24|Safety assessed by ophthalmological examination: Optical coherence tomography, Up to Week 24|Safety assessed by ophthalmological examination: visual acuity, Up to Week 24
Sponsor/Collaborators: Sponsor: Astellas Pharma Inc | Collaborators: FibroGen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 303
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2016-11-30
Completion Date: 2018-03-15
Results First Posted:
Last Update Posted: 2024-10-30
Locations: Site JP00008, Aichi, Japan|Site JP00018, Aichi, Japan|Site JP00020, Aichi, Japan|Site JP00032, Aichi, Japan|Site JP00033, Aichi, Japan|Site JP00040, Aichi, Japan|Site JP00004, Ehime, Japan|Site JP00055, Ehime, Japan|Site JP00009, Fukui, Japan|Site JP00059, Fukui, Japan|Site JP00014, Fukuoka, Japan|Site JP00049, Fukuoka, Japan|Site JP00010, Fukushima, Japan|Site JP00056, Fukushima, Japan|Site JP00057, Fukushima, Japan|Site JP00030, Gifu, Japan|Site JP00050, Gifu, Japan|Site JP00011, Gunma, Japan|Site JP00026, Gunma, Japan|Site JP00037, Gunma, Japan|Site JP00003, Hokkaido, Japan|Site JP00031, Hokkaido, Japan|Site JP00038, Hokkaido, Japan|Site JP00048, Hokkaido, Japan|Site JP00017, Ibaraki, Japan|Site JP00041, Ibaraki, Japan|Site JP00042, Ibaraki, Japan|Site JP00045, Ibaraki, Japan|Site JP00046, Ibaraki, Japan|Site JP00047, Ibaraki, Japan|Site JP00054, Ibaraki, Japan|Site JP00058, Ibaraki, Japan|Site JP00043, Kagoshima, Japan|Site JP00005, Kanagawa, Japan|Site JP00028, Kumamoto, Japan|Site JP00029, Kumamoto, Japan|Site JP00006, Kyoto, Japan|Site JP00002, Nagano, Japan|Site JP00012, Nagano, Japan|Site JP00027, Nagano, Japan|Site JP00051, Nagano, Japan|Site JP00013, Nagasaki, Japan|Site JP00001, Niigata, Japan|Site JP00034, Niigata, Japan|Site JP00036, Okayama, Japan|Site JP00007, Osaka, Japan|Site JP00015, Osaka, Japan|Site JP00016, Saitama, Japan|Site JP00035, Saitama, Japan|Site JP00044, Tokushima, Japan|Site JP00052, Tokyo, Japan|Site JP00053, Tokyo, Japan|Site JP00021, Toyama, Japan|Site JP00022, Toyama, Japan|Site JP00039, Toyama, Japan|Site JP00024, Yamagata, Japan|Site JP00025, Yamaguchi, Japan
URL: https://clinicaltrials.gov/show/NCT02952092