National Cooperative Growth Study in CKD (NCGS)

• ClinicalTrials.gov Identifier: NCT00616278
• Recruitment Status: Completed
• First Posted: February 15, 2008
• Last Update Posted: May 30, 2017
• Sponsor: University of California, Davis
• Collaborator: Genentech, Inc.
• Information provided by (Responsible Party): University of California, Davis

Tracking Information

• First Submitted Date: February 4, 2008
• First Posted Date: February 15, 2008
• Last Update Posted Date: May 30, 2017
• Study Start Date: October 2005
• Actual Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 14, 2008): 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 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: National Cooperative Growth Study in CKD
• 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)
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: pediatric clinic
• Condition: Growth Hormone Deficiency
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 22, 2012): 27
• Original Estimated Enrollment (submitted: February 14, 2008): 50
• Actual Study Completion Date: February 2010
• Actual Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00616278
• Other Study ID Numbers: 200412150
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of California, Davis
• Study Sponsor: University of California, Davis
• Collaborators: Genentech, Inc.

Investigators

• Principal Investigator: Lavjay Butani, M.D.; University of California, Davis

• PRS Account: University of California, Davis
• Verification Date: May 2017