National Cooperative Growth Study in CKD (NCGS)

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Lavjay Butani, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00616278
First received: February 4, 2008
Last updated: November 22, 2012
Last verified: November 2012
  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: Observational Model: Cohort
Time Perspective: 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:


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 ]

Enrollment: 27
Study Start Date: October 2005
Study Completion Date: February 2010
Primary Completion Date: February 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

Locations
United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Genentech
Investigators
Principal Investigator: Lavjay Butani, M.D. University of California, Davis
  More Information

Additional Information:
No publications provided

Responsible Party: Lavjay Butani, MD, Associate Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT00616278     History of Changes
Other Study ID Numbers: 200412150-5
Study First Received: February 4, 2008
Last Updated: November 22, 2012
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, Pituitary
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 15, 2014