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National Cooperative Growth Study in CKD (NCGS)

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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

Study Description
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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.

Condition or disease
Growth Hormone Deficiency

Study Design
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Study Type : Observational
Actual Enrollment : 27 participants
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)
Study Start Date : October 2005
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616278


Locations
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United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Genentech, Inc.
Investigators
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Principal Investigator: Lavjay Butani, M.D. University of California, Davis
More Information
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00616278    
Other Study ID Numbers: 200412150
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Keywords provided by University of California, Davis:
Growth Failure AND
Chronic Renal Insufficiency OR
End Stage Renal Disease
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases