A Multicenter Study Evaluating Once Weekly Intravenous Administration of Aranesp® in Subjects With End Stage Renal Disease on Chronic Hemodialysis

Amgen0 个研究点开始时间: 2005年7月4日最近更新: 2009年10月16日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Amgen
主要终点: Target hemoglobin (Hgb)

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the Aranesp® dose administered intravenously (IV) once weekly to maintain hemoglobin (Hgb) levels in hemodialysis subjects who are either recombinant human erythropoietin (rHuEPO) naïve or subjects converted from rHuEPO therapy administered IV thrice weekly (TIW).

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Subjects with end stage renal disease (ESRD) on hemodialysis

排除标准

•Known hypersensitivity to Aranesp® (darbepoetin alfa) or any of its excipients - Participating in an investigational drug or device trial - Patient will not be available for follow-up assessment - Patient has any disorder that compromises the ability of the patient to give written informed consent and/or to comply with study procedures

结局指标

主要结局

Target hemoglobin (Hgb)

次要结局

Distribution of hemoglobin (Hgb) values by week

研究者

发起方

Amgen

申办方类型

Industry

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