跳至主要内容
临床试验/EUCTR2006-003173-27-IT
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

发起方
AMGEN S.P.A.

相似试验