A Phase 3, Multicenter, Randomized, Open-label, Active-Controlled Study of the Safety and Efficacy of Roxadustat in the Treatment of Anemia in Dialysis Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 2,133
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of roxadustat compared to epoetin alfa for the treatment of anemia in chronic kidney disease patients on dialysis.
详细描述
This is a Phase 3, multicenter, randomized, open-label, active-controlled study to evaluate the efficacy and safety of roxadustat compared to epoetin alfa for the treatment of anemia in dialysis patients. Patients on hemodialysis (HD) or peritoneal dialysis (PD) who have been treated with an erythropoietin analogue or have an indication for treatment with an erythropoietin analogue will be evaluated for eligibility and randomized at a 1:1 ratio to treatment with roxadustat (with discontinuation of prior erythropoietin analogue therapy) or to an active-control group treated with epoetin alfa
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
- None
入排标准
- 年龄范围
- 18 Years 至 130 Years（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
Roxadustat
干预措施: Roxadustat (Drug)
Epoetin alfa
干预措施: Epoetin alfa (Drug)
结局指标
主要结局
Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52
时间窗: Baseline (Day 1, Week 0), Week 28 to 52
Baseline Hb was defined as the mean of the three last central laboratory Hb values from the screening and randomization visits. Mean change in Hb from baseline to the participants mean level from Week 28 to Week 52 was analyzed using a missing at random (MAR) based multiple imputation Analysis of Covariance (ANCOVA). Baseline Hb was used as a covariate and treatment group, cardiovascular (CV) history, geographic region and dialysis duration as fixed effects. The adjusted least squares (LS) mean estimates of change from baseline during Week 28 to Week 52 are presented.
次要结局
- Change in Hb From Baseline to the Mean Level During the Evaluation Period (Week 28 to Week 36) Without Having Received Rescue Therapy Within 6 Weeks Prior to and During the 8-Week Evaluation Period(Baseline (Day 1, Week 0), Week 28 to 36)
- Proportion of Total Time of Hb Within the Interval of >=10 g/dL From Week 28 to Week 52(Week 28 to 52)
- Proportion of Total Time of Hb Within the Interval of 10 to 12 g/dL From Week 28 to Week 52(Week 28 to 52)
- Mean Change in Low-Density Lipoprotein (LDL) Cholesterol From Baseline to Week 24(Baseline (Day 1, Week 0) to Week 24)
- Mean Change in Hb From Baseline to the Participant's Mean Level Between Week 28 to Week 52 in Participants With Baseline High-Sensitivity C-Reactive Protein (hsCRP) Greater Than the Upper Limit of Normal (ULN)(Baseline (Day 1, Week 0), Week 28 to 52)
- Mean Monthly IV Iron Use From Week 36 to End of Study (EOS)(Week 36 to EOS (4 weeks after the treatment period))
- Time-To-First Administration of RBC Transfusion as Rescue Therapy(Baseline (Day 1, Week 0) up to EOS (4 weeks after the treatment period))