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临床试验/EUCTR2006-000074-79-IT
EUCTR2006-000074-79-IT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 - ND

AMGEN S.P.A.0 个研究点目标入组 100 人开始时间: 2006年8月30日最近更新:
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
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

  • 8805; 18 years of age Receiving dialysis for 8805; 3 months before enrollment The mean of 2 screening Hb values taken at least 7 days apart must be 8805; 11.0 g/dL and 8804; 13.0 g/dL The 2 screening Hb values must be 8805; 11 g/dL and 8804; 13 g/dL Receiving stable QW darbepoetin alfa doses for at least 6 weeks before enrollment defined as 8804; 25 change in dose over the 6-week period immediately prior to enrollment and no change in frequency Adequate iron stores serum ferritin 100 g/
  • 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

发起方
AMGEN S.P.A.

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A Multicenter, Single Arm Study Evaluating The... | 临床试验