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National Cooperative Growth Study in CKD (NCGS)

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.
 
ClinicalTrials.gov Identifier: NCT00616278
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : May 30, 2017
Sponsor:
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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