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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