A Single Arm, Open Label, French Multi-centre Study to Assess the Maintenance of Hemoglobin Levels With Once Monthly Subcutaneous Administration of C.E.R.A. (Continuous Erythropoietin Receptor Activator) in Patients With Chronic Kidney Disease Not on Dialysis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 127
- 主要终点
- Proportion of patients maintaining average Hb concentration within target range of 10-12g/dL during evaluation period
研究概览
简要总结
This single arm study will assess the efficacy and safety of monthly administration of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving treatment with subcutaneous epoetin or darbepoetin alfa will receive monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta, with the starting dose (120 or 200 micrograms) calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered.
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
- •chronic kidney disease stage 3 or 4, with chronic renal anemia, not requiring dialysis;
- •continuous stable subcutaneous maintenance Erythropoietin-Stimulating Agent (ESA) therapy during previous month.
排除标准
- •transfusion of red blood cells during previous 2 months;
- •significant acute or chronic bleeding;
- •poorly controlled hypertension.
研究组 & 干预措施
Methoxy Polyethylene Glycol-epoetin Beta
Participants will receive subcutaneous methoxy polyethylene glycol-epoetin beta every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) will be determined based on the previous dose of epoetin or darbepoetin received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.
干预措施: Methoxy Polyethylene Glycol-epoetin Beta (Drug)
结局指标
主要结局
Proportion of patients maintaining average Hb concentration within target range of 10-12g/dL during evaluation period
时间窗: Weeks 16-24
次要结局
- AEs, lab parameters(Throughout study)
- Mean time spent in Hb range(Weeks 16-24)
- Mean change in Hb concentration(Between reference and Efficacy Evaluation Period)
- % patients maintaining Hb concentration within target range; % patients requiring dose adjustments; incidence of RBC transfusions(Weeks 16-48)