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A Study in Children With Growth Failure Due to Chronic Renal Insufficiency (CRI) or End Stage Renal Disease (ESRD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00097617
First Posted: November 25, 2004
Last Update Posted: November 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
November 24, 2004
November 25, 2004
November 14, 2012
March 2002
July 2010   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00097617 on ClinicalTrials.gov Archive Site
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A Study in Children With Growth Failure Due to Chronic Renal Insufficiency (CRI) or End Stage Renal Disease (ESRD)
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)
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
primary care clinic
  • Chronic Renal Insufficiency
  • End-Stage Renal Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
395
July 2010
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00097617
85-036, Substudy 11
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Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Barbara Lippe, M.D. Genentech, Inc.
Genentech, Inc.
November 2012