National Cooperative Growth Study (NCGS) of Nutropin AQ, Nutropin, and Protropin in Children With Growth Failure Due to Chronic Renal Insufficiency (CRI) or End Stage Renal Disease (ESRD)

Genentech, Inc.0 个研究点目标入组 395 人开始时间: 2002年3月最近更新: 2012年11月14日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Genentech, Inc.
入组人数: 395

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

This study is a multicenter, open-label, observational, postmarketing surveillance study that will collect information on the use of Genentech growth hormone (GH) preparations to treat children with CRI in the United States.

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: — 至 17 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Children diagnosed with CRI or ESRD and treated with a Genentech GH preparation on or after 1 January 2001
•CRI documented using the Schwartz formula indicates a calculated creatinine clearance (CrCl) of <=75 mL/min/1.73 m^2
•Ability to keep follow up appointments throughout the study

排除标准

•Subjects receiving a non-Genentech GH preparation
•Subjects with closed epiphyses
•Subjects with active neoplasia
•Current participation in another GH clinical study
•Current participation in the core study

研究者

发起方

Genentech, Inc.

申办方类型

Industry

责任方

Sponsor

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