National Cooperative Growth Study of Nutropin AQ, Nutropin, Protropin, and Nutropin Depot in Children With Growth Failure Due to Chronic Renal Insufficiency or End-Stage Renal Disease - Full Text View

National Cooperative Growth Study of Nutropin AQ, Nutropin, Protropin, and Nutropin Depot in Children With Growth Failure Due to Chronic Renal Insufficiency or End-Stage Renal Disease (NCGS)

This study is currently recruiting participants.

Verified by University of California, Davis, February 2008

First Received: February 4, 2008 Last Updated: February 14, 2008 History of Changes

Sponsor:	University of California, Davis
Collaborator:	Genentech
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00616278

Purpose

The purpose of this study is to learn whether growth hormone being administered to children with Chronic Kidney Disease is effective and if it has any side effects.

Condition
Growth Hormone Deficiency

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	National Cooperative Growth Study of Nutropin AQ, Nutropin, Protropin, and Nutropin Depot in Children With Growth Failure Due to Chronic Renal Insufficiency (CRI) or End-Stage Renal Disease (ESRD)

Resource links provided by NLM:

Genetics Home Reference related topics: pseudoachondroplasia

Drug Information available for: Somatropin Somatrem Somatotropin

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:

The primary outcome measures of the NCGS are ongoing safety and efficacy of Genentech GH preparations in pediatric growth disorders for which GH is initiated. [ Time Frame: per the study, the pt will be on GH treatement until the physician instructs them to stop ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	50
Study Start Date:	October 2005
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

pediatric clinic

Criteria

Inclusion Criteria:

Must be a patient of the UC Davis Medical Center pediatric clinic with Chronic Kidney Disease

Exclusion Criteria:

Greater than 18 years old
Not a patient at the UC Davis Medical Center pediatric clinic

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616278

Contacts

Contact: J. Gularte

(916) 734-7222

Locations

United States, California
UC Davis Medical Center	Recruiting
Sacramento, California, United States, 95817
Principal Investigator: Lavjay Butani, MD

Sponsors and Collaborators

University of California, Davis

Genentech

Investigators

Principal Investigator:

Lavjay Butani, M.D.

University of California, Davis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of California, Davis Medical Center ( Lavjay Butani, M.D./ Associate Professor & Section Chief of Pediatric Nephrology )
Study ID Numbers:	200412150-5
Study First Received:	February 4, 2008
Last Updated:	February 14, 2008
ClinicalTrials.gov Identifier:	NCT00616278 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Davis:

Growth Failure AND
Chronic Renal Insufficiency OR
End Stage Renal Disease

Additional relevant MeSH terms:

Dwarfism
Bone Diseases, Endocrine
Hypothalamic Diseases
Renal Insufficiency
Pituitary Diseases
Nervous System Diseases
Kidney Failure, Chronic
Central Nervous System Diseases
Endocrine System Diseases
Dwarfism, Pituitary

Brain Diseases
Bone Diseases
Urologic Diseases
Musculoskeletal Diseases
Hypopituitarism
Renal Insufficiency, Chronic
Bone Diseases, Developmental
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on February 08, 2010