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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.
  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:


Further study details as provided by Genentech, Inc.:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00097617     History of Changes
Other Study ID Numbers: 85-036, Substudy 11
First Submitted: November 24, 2004
First Posted: November 25, 2004
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