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

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ClinicalTrials.gov Identifier: NCT00097617
Recruitment Status : Completed
First Posted : November 25, 2004
Last Update Posted : November 14, 2012
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
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.

Condition or disease Phase
Chronic Renal Insufficiency End-Stage Renal Disease Phase 4

Study Type : Observational
Actual Enrollment : 395 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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 Start Date : March 2002
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00097617


Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Barbara Lippe, M.D. Genentech, Inc.

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00097617     History of Changes
Other Study ID Numbers: 85-036, Substudy 11
First Posted: November 25, 2004    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Failure to Thrive
Urologic Diseases
Signs and Symptoms