Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Subjects Receiving Hemodialysis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Mean Hemoglobin Concentration During the Evaluation Period
研究概览
简要总结
The purpose of this study is to evaluate whether hemodialysis patients on peginesatide can be converted to epoetin alfa by using a predefined conversion table while achieving a stable hemoglobin.
详细描述
This is a phase 4, multicenter, single-arm, open-label study designed to evaluate whether patients receiving hemodialysis and treated with peginesatide can be converted to epoetin alfa using a predefined conversion table while achieving stable hemoglobin. The study will be conducted in two phases. Hemodialysis patients treated with epoetin alfa 3 times a week (TIW) will first be converted to peginesatide administered every 4 weeks (Q4W). After 24 weeks, these participants will be converted back to epoetin alfa administered TIW for 32 weeks. The primary endpoint will be the mean hemoglobin during the last 8 weeks of the epoetin alfa period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving hemodialysis 3 times a week
- •Receiving epoetin alfa IV 3 times a week
- •Hemoglobin concentration ≥ 9.0 and ≤ 12.0 g/dL within 8 weeks of or during screening
排除标准
- •Systemic hematologic disease
- •Changes in Epoetin alfa dose by ≥ 50% within 8 weeks of or during screening
研究组 & 干预措施
Peginesatide / Epoetin Alfa
Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
干预措施: Peginesatide (Drug)
Peginesatide / Epoetin Alfa
Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
干预措施: Epoetin alfa (Drug)
结局指标
主要结局
Mean Hemoglobin Concentration During the Evaluation Period
时间窗: Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).
The hemoglobin concentrations during the evaluation period after the conversion to epoetin alfa were to be averaged for each participant and then summarized over all participants. No participant reached the evaluation period, therefore, the primary efficacy endpoint could not be evaluated.
次要结局
- Peginesatide Dose by Visit(Baseline and Weeks 5, 9, 13, and 17)
- Hemoglobin Concentration by Visit(Baseline and Weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21)
- Mean Dose of Epoetin Alfa During the Evaluation Period(Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).)