A Randomised, Controlled, Open-label, French Multicenter Parallel Group Study to Compare the Maintenance of Haemoglobin Level With Once Monthly Administration of C.E.R.A. (Continuous Erythropoietin Receptor Activator) Versus Epoetin Beta or Darbepoetin Alfa in Patients With Chronic Kidney Disease on Haemodialysis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 421
- 主要终点
- Percentage of patients maintaining average Hb concentration within target range (10-12g/dL) during evaluation period.
研究概览
简要总结
This 2 arm study will compare the hemoglobin maintenance with once monthly methoxy polyethylene glycol-epoetin beta (Mircera) administration versus epoetin beta or darbepoetin alfa in participants with chronic kidney disease on hemodialysis. Participants will be randomized to receive either monthly intravenous (IV) or subcutaneous (SC) methoxy polyethylene glycol-epoetin beta (at a starting dose of 120 or 200 micrograms, calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered), or standard therapy (IV or SC epoetin beta once, twice or thrice weekly, or IV or SC darbepoetin alfa once a week or twice a week).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •regular long term hemodialysis with same schedule for greater than or equal to (>=) 12 weeks
- •continuous IV or SC maintenance epoetin beta or darbepoetin alfa therapy, with the same dosing interval during the previous month, and no change in total weekly dose
排除标准
- •transfusion of red blood cells during previous 2 months
- •significant acute or chronic bleeding
- •poorly controlled hypertension requiring hospitalization or interruption of epoetin beta/darbepoetin alfa treatment in previous 6 months
- •weekly dose of epoetin beta greater than (>) 16000 international units (IU), or weekly dose of darbepoetin alfa >80 micrograms during previous month
研究组 & 干预措施
Methoxy Polyethylene Glycol-epoetin Beta
Participants who are receiving SC or IV epoetin beta or darbepoetin alfa will receive monthly injections of methoxy polyethylene glycol-epoetin beta, with the starting dose of 120 or 200 micrograms calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered, using the same route of administration (SC or IV). Thereafter, when the hemoglobin concentration will increase or decrease in a clinically significant amount, a dose adjustment will be performed according to specific provided guidance. Total duration of treatment will be up to 48 weeks.
干预措施: Methoxy Polyethylene Glycol-epoetin Beta (Drug)
Epoetin Beta or Darbepoetin Alfa
Participants who are receiving SC or IV epoetin beta or darbepoetin alfa will continue to receive the same treatment (epoetin beta or darbepoetin alfa at the same dose, same administration intervals, and the same route of administration). When necessary, dose adjustments will be performed according to Summary of Product Characteristics (SmPC). Total duration of treatment will be up to 48 weeks.
干预措施: Epoetin Beta (Drug)
Epoetin Beta or Darbepoetin Alfa
Participants who are receiving SC or IV epoetin beta or darbepoetin alfa will continue to receive the same treatment (epoetin beta or darbepoetin alfa at the same dose, same administration intervals, and the same route of administration). When necessary, dose adjustments will be performed according to Summary of Product Characteristics (SmPC). Total duration of treatment will be up to 48 weeks.
干预措施: Darbepoetin Alfa (Drug)
结局指标
主要结局
Percentage of patients maintaining average Hb concentration within target range (10-12g/dL) during evaluation period.
时间窗: Weeks 16-24
次要结局
- Mean change in Hb concentration between reference and evaluation period, and mean time spent in Hb range of 10-12g/dL during evaluation period.(Weeks 16-24)
- Dose adjustments, RBC transfusions, AEs.(Throughout study)