An Open Label Randomised Controlled Study to Compare the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. Versus Epoetin Alfa for the Maintenance of Haemoglobin Levels in Hemodialysis Patients With Chronic Renal Anaemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 101
- 主要终点
- Percentage of Participants Who Maintained Average Hemoglobin (Hb) Concentration Within Plus Minus (+/-) 1 Grams Per Deciliter (g/dL) of Their Reference Hb and Between 10 and 12 g/dL During the EEP
研究概览
简要总结
This 2 arm study will compare the efficacy and safety of monthly administration of intravenous (IV) Mircera versus epoetin alfa for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Participants currently receiving maintenance treatment with epoetin alfa will be randomized either to receive monthly injections of 120, 200 or 360 micrograms Mircera, with the starting dose derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. The anticipated duration of study is 32 weeks, and the target sample size is 146 participants.
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
- •chronic renal anemia;
- •continuous iv maintenance epoetin alfa therapy, with the same dosing interval during the previous month to and during SVP;
- •regular hemodialysis for greater than or equal to (>=) 3 months
排除标准
- •transfusion of red blood cells during previous 2 months
- •poorly controlled hypertension requiring interruption of epoetin alfa treatment in previous 6 months;
研究组 & 干预措施
C.E.R.A
Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
干预措施: methoxy polyethylene glycol-epoetin beta (Drug)
Epoetin Alfa
Participants received IV injection of 6000 International Units (IU) of epoetin alfa every 3 weeks (q3wk) during the Stability Verification Period (SVP; Week -4 to -1), and 7443 IU of epoetin alfa q3wk during Dose Titration Period (DTP; Week 0 to 15), 7363 IU of epoetin alfa q3wk during Efficacy Evaluation Period (EEP; Week 16 to 23) up to 23 weeks.
干预措施: Epoetin alfa (Drug)
结局指标
主要结局
Percentage of Participants Who Maintained Average Hemoglobin (Hb) Concentration Within Plus Minus (+/-) 1 Grams Per Deciliter (g/dL) of Their Reference Hb and Between 10 and 12 g/dL During the EEP
时间窗: EEP (Week 16 to 23)
Participants who maintained average Hb concentration within +/-1 g/dL of their reference Hb and between 10 to 12 g/dL during EEP are reported. The reference Hb value was defined on the basis of all assessments at Weeks -4, -3, -2, -1 and 0.
次要结局
- Percentage of Participants Who Maintained Hb Concentration Between 10 and 12 g/dL Throughout the EEP(EEP (Week 16 to 23))
- Percentage of Participants Who Required Dose Adjustments During the DTP and EEP(DTP (Week 0 to 15) and EEP (Week 16 to 23))
- Change in Hb Concentrations Between Baseline SVP and the EEP(SVP (Week -4 to -1), EEP (Week 16 to 23))
- Mean Time Spent in Hb Range 10-12 g/dL(SVP (Week -4 to -1), DTP (Week 0 to 15), and EEP (Week 16 to 23))
- Percentage of Participants Who Received Red Blood Cell (RBC) Transfusions During DTP and EEP(DTP (Week 0 to 15) up to EEP (Week 16 to 23))