A 52-week, Phase III, Double-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate Efficacy and Safety of Daprodustat Compared to Darbepoetin Alfa in Japanese Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease Who Are Currently ESA Users
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 271
- 试验地点
- 1
- 主要终点
- Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)
研究概览
简要总结
Daprodustat is a drug that is currently being developed as a treatment for renal anemia . This study is to evaluate the efficacy and safety of daprodustat following a switch from erythropoiesis-stimulating agent (ESA) in Japanese HD subjects with renal anemia who are currently treated with ESA. The primary objective is to demonstrate non-inferiority of daprodustat to darbepoetin alfa. This study is a 52-week, Phase III, double-blind, active-controlled, parallel-group, multi-center study. The total duration of the study will be approximately 58 weeks including screening and follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Daprodustat
Subjects will receive oral daprodustat once daily and intravenous (IV) darbepoetin alfa placebo once weekly for 52 weeks
干预措施: Daprodustat small (Drug)
Daprodustat
Subjects will receive oral daprodustat once daily and intravenous (IV) darbepoetin alfa placebo once weekly for 52 weeks
干预措施: Daprodustat large (Drug)
Daprodustat
Subjects will receive oral daprodustat once daily and intravenous (IV) darbepoetin alfa placebo once weekly for 52 weeks
干预措施: Darbepoetin alfa placebo (Drug)
Darbepoetin alfa
Subjects will receive IV darbepoetin alfa once weekly and oral daprodustat placebo once daily for 52 weeks
干预措施: Daprodustat small placebo (Drug)
Darbepoetin alfa
Subjects will receive IV darbepoetin alfa once weekly and oral daprodustat placebo once daily for 52 weeks
干预措施: Daprodustat large placebo (Drug)
Darbepoetin alfa
Subjects will receive IV darbepoetin alfa once weekly and oral daprodustat placebo once daily for 52 weeks
干预措施: Darbepoetin alfa (Drug)
结局指标
主要结局
Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)
时间窗: Weeks 40 to 52
The mean hemoglobin during the Evaluation Period was estimated by a statistical model.
次要结局
- Percentage of Participants With Mean Hgb in the Target Range (10.0-12.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)(Weeks 40 to 52)
- Change From Baseline in Hgb (Hgb Increase Rate) at Week 4(Baseline and Week 4)
- Percentage of Participants by Hgb Change From Baseline Category at Week 4(Week 4)
- Distribution of Daprodustat Dose Level by Visit(Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44, and 48))
- Distribution of Darbepoetin Alfa Dose Level by Visit(Day 1, Weeks 2,4,6,8,10,12,14,16,18,20,22,24,26,28,30,32,34,36,38,40,42,44,46,48, and 50)
- Duration of Treatment Interruption Due to Hgb >13 g/dL(Up to Week 52)
- Number of Dose Adjustments for Daprodustat(Up to Week 52)
- Hgb Values at Each Assessment Visit(Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52)
- Change From Baseline in Hgb Values at Each Assessment Visit(Baseline (Day 1) and Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52)
- Percentage of Participants Who Had Hgb Level Within the Target Range (10.0-12.0 g/dL) at Each Assessment Visit(Baseline (Day 1) and Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52)
- Percentage of Time in Hgb Target Range (10.0 to 12.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)(Weeks 40 to 52)
- Number of Participants Who Had an Hgb Level of Less Than 7.5 g/dL(Up to Week 52)
- Number of Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks(Up to Week 52)
- Number of Participants Who Had an Hgb Level of More Than 13.0 g/dL(Up to Week 52)
- Number of Episodes With Hgb Level of More Than 13.0 g/dL(Up to Week 52)
- Area Under Plasma Concentration Curve From Time Zero to 4 Hours (AUC [0 - 4]) of Plasma Daprodustat(0, 1, 2, 3, and 4 hours post-dose at Week 12 and Week 24)
- Maximum Concentration (Cmax) of Plasma Daprodustat(0, 1, 2, 3, and 4 hours post-dose at Week 12 and Week 24)