EUCTR2006-003173-27-IT进行中(未招募)不适用
A Multi-Center, Single Arm Study Evaluating De Novo Once Monthly Darbepoetin Alfa Dosing for the Correction of Anemia in Subjects with Chronic Kidney Disease Not Receiving Dialysis - Darbepoetin Alfa 20060163
AMGEN S.P.A.0 个研究点目标入组 155 人开始时间: 2006年12月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 155
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
- •8805; 18 years of age Estimated Glomerular Filtration Rate eGFR of 8805; 15 mL/min/1.73 m2 - 8804; 60 mL/min/1.73 m2 MDRD equation The mean of two screening Hb values taken at least 7 days apart must be 11.0 g/dL Serum Ferritin 8805; 100 g/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
- •Upper or lower GI bleeding within the prior 6 months ESA use within 12 weeks before enrollment Uncontrolled hypertension Other hematologic disorders Prior history within 12 weeks before enrollment of events including o Acute myocardial ischemia o Hospitalization for congestive heart failure o Myocardial infarction o Deep vein thrombosis, stroke or transient ischemic attack
研究者
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