An Open Label Randomized Controlled Study to Compare the Efficacy and Safety of Once Every 4 Weeks Administration of Mircera Versus Short-acting Epoetin for the Maintenance of Hemoglobin Levels in Dialysis Patients With Chronic Renal Anemia.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 281
- 主要终点
- Change in hemoglobin concentration between baseline and the EEP
研究概览
简要总结
This two arm study will compare the maintenance of hemoglobin levels, safety and tolerability of once every 4 weeks subcutaneous administration of Mircera versus epoetin beta in dialysis patients with chronic renal anemia. Patients will be randomized to receive either subcutaneous Mircera (starting dose 120, 200 or 360 micrograms) every 4 weeks or subcutaneous epoetin beta in accordance with the prescribed dosing information. In both groups, the starting dose will be the same as the previous dose of epoetin beta administered in the week preceding first study drug administration. Patients will be treated for 28 weeks with follow up 4 weeks after the last treatment visit. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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
- •male or female patients, >=18 years of age;
- •chronic renal anemia;
- •Hb concentration 10.0 - 12.0 g/dL during the screening period;
- •continuous subcutaneous maintenance therapy with epoetin at the same dose AND same dosing interval for at least 12 weeks before and throughout screening.
排除标准
- •blood transfusion within the previous 8 weeks;
- •poorly controlled hypertension;
- •significant or acute or chronic bleeding;
- •active malignant disease;
- •congestive heart failure (NYHA Class IV).
研究组 & 干预措施
1
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
2
干预措施: epoetin beta (Drug)
结局指标
主要结局
Change in hemoglobin concentration between baseline and the EEP
时间窗: Week 20-28
次要结局
- Incidence of adverse events and serious adverse events; vital signs, laboratory parameters, ECG.(Throughout study)
- Proportion of patients maintaining average Hb concentration within the target range during the EEP; proportion of patients maintaining Hb concentration between 10-12g/dL throughout the EEP.(Weeks 1-28)
- Mean time spent in the Hb range 10 - 12g/dL; incidence of red blood cell transfusions during the DTP and EEP.(Weeks 1-28)