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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:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00097617
First received: November 24, 2004
Last updated: November 13, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Phase
Chronic Renal Insufficiency
End-Stage Renal Disease
 Phase 4

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Genentech:

Enrollment: 395
Study Start Date: March 2002
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00097617

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

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00097617     History of Changes
Other Study ID Numbers: 85-036, Substudy 11
Study First Received: November 24, 2004
Last Updated: November 13, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Failure to Thrive
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
 Renal Insufficiency
Growth Disorders
Pathologic Processes
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013