A Study in Children With Growth Failure Due to Chronic Renal Insufficiency (CRI) or End Stage Renal Disease (ESRD)
Overview
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.
Full Title of Study: “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)”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: July 2010
Participating in This Clinical Trial
Inclusion Criteria
- 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 Exclusion Criteria:
- 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
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: 17 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Genentech, Inc.
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Barbara Lippe, M.D., Study Director, Genentech, Inc.
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