NCT00081471已完成3 期
A Randomized, Open-label Study of the Effect of Subcutaneous Mircera on Hemoglobin Level/Correction in Non-dialysis Patients With Chronic Kidney Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 324
- 主要终点
- Hemoglobin response rate
研究概览
简要总结
This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years 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
- •adult patients >=18 years of age;
- •chronic kidney disease;
- •not on dialysis therapy;
- •not receiving epoetin.
排除标准
- •women who are pregnant, breastfeeding or using unreliable birth control methods;
- •administration of another investigational drug within 4 weeks before screening, or during the study period.
研究组 & 干预措施
1
Experimental
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
2
Active Comparator
干预措施: darbepoetin alfa (Drug)
结局指标
主要结局
Hemoglobin response rate
时间窗: Weeks 1-28
次要结局
- Hb concentration over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, adverse events, laboratory values\n\n(Throughout study)
研究者
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