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

This study is ongoing, but not recruiting participants.

First Received on November 24, 2004. Last Updated on November 11, 2010 History of Changes

Sponsor:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00097617

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 IV

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:

MedlinePlus related topics: Kidney Failure

U.S. FDA Resources

Further study details as provided by Genentech:

Enrollment:	395
Study Start Date:	March 2002
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	June 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:	Disclosures Group, Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT00097617 History of Changes
Other Study ID Numbers:	85-036, Substudy 11
Study First Received:	November 24, 2004
Last Updated:	November 11, 2010
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 February 09, 2012