Prospective Study Evaluating the Quality of Life in Dialysis Patients With End Stage Renal Disease

Hoffmann-La Roche0 个研究点目标入组 6,000 人开始时间: 2008年12月最近更新: 2012年9月13日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Hoffmann-La Roche
入组人数: 6,000
主要终点: Quality of life assessment: Kidney Disease Quality of Life Questionnaire

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

This multicenter, prospective, observational study will evaluate the quality of life and the factors that influence the quality of life of epoetin beta [Neorecormon] in patients with renal chronic anemia, who are on dialysis. For each eligible patient data will be collected for 6 months. Target sample size is 5000-7000 patients.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

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

•Adult patients >/=18 years of age
•Dialysis patients with chronic renal anemia
•Written informed consent

排除标准

•Red blood cell transfusion in the previous 2 months
•Severe neuropsychological disorder
•Diabetic patients with serious complications
•This trial is being conducted in Morocco.

结局指标

主要结局

Quality of life assessment: Kidney Disease Quality of Life Questionnaire

时间窗: Throughout study: 6 months

次要结局

Evaluation of factors (demographic and social characteristics, dialysis method) influencing the quality of life(Throughout study: 6 months)

研究者

发起方

Hoffmann-La Roche

申办方类型

Industry

责任方

Sponsor

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