NCT00437723已完成4 期
An Open-Label Study to Investigate the Effect of NeoRecormon on Hemoglobin Level and Renal Function in Patients With Chronic Kidney Disease, Stage 2-4
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Hb level, decline in renal function, 24h proteinuria, creatinine clearance.
研究概览
简要总结
This 2 arm study will compare the level of anemia, and the decline in renal function, between patients receiving NeoRecormon, and those not receiving it. Patients with chronic kidney disease, stage 2-4, and not receiving dialysis, will be randomized 2:1 to a group receiving NeoRecormon (at a dose determined by the investigator to achieve and maintain an Hb level of 120-135 g/L), or to a control group not receiving NeoRecormon. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients,18-75 years of age;
- •end-stage renal disease, not on dialysis;
- •Hb <110g/L.
排除标准
- •unstable hypertension;
- •acute infections;
- •use of i.v. NeoRecormon, or use of any other ESA beside NeoRecormon;
- •myocardial infarction, unstable angina or venous thrombosis within 6 months before start of treatment.
研究组 & 干预措施
1
Experimental
干预措施: epoetin beta [NeoRecormon] (Drug)
结局指标
主要结局
Hb level, decline in renal function, 24h proteinuria, creatinine clearance.
时间窗: Throughout study
次要结局
- SAEs, AEs leading to withdrawal, AEs related to NeoRecormon.(Throughout study)
研究者
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