EUCTR2006-000074-79-DE进行中（未招募）不适用
A Multicenter, Single Arm Study Evaluating The Extension From Weekly To Once Every Other Week Darbepoetin Alfa Administration In Subjects With Chronic Kidney Disease Receiving Dialysis.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Amgen Ltd
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •= 18 years of age
- •Receiving dialysis for = 3 months before enrollment
- •The mean of 2 screening Hb values taken at least 7 days apart must be = 11.0 g/dL and = 13.0 g/dL
- •The 2 screening Hb values must be = 11 g/dL and = 13 g/dL
- •Receiving stable QW darbepoetin alfa doses for at least 6 weeks before enrollment (defined as = 25% change in dose over the 6-week period immediately prior to enrollment and no change in frequency)
- •Adequate iron stores (serum ferritin > 100 µg/L)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Uncontrolled hypertension
- •Prior history (within 12 weeks before enrollment) of events including: acute myocardial ischemia, hospitalization for congestive heart failure, myocardial infarction, deep vein thrombosis, stroke or transient ischemic attack
- •Other hematological disorders
- •Upper or lower GI bleeding within the prior 6 months
研究者
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