Status:
COMPLETED
A Study in Children With Growth Failure Due to Chronic Renal Insufficiency (CRI) or End Stage Renal Disease (ESRD)
Lead Sponsor:
Genentech, Inc.
Conditions:
Chronic Renal Insufficiency
End-Stage Renal Disease
Eligibility:
All Genders
Up to 17 years
Brief Summary
This study is a multicenter, open-label, observational, postmarketing surveillance study that will collect information on the use of Genentech growth hormone (GH) preparations to treat children with C...
Eligibility Criteria
Inclusion
- Children diagnosed with CRI or ESRD and treated with a Genentech GH preparation on or after 1 January 2001
- CRI documented using the Schwartz formula indicates a calculated creatinine clearance (CrCl) of \<=75 mL/min/1.73 m\^2
- Ability to keep follow up appointments throughout the study
Exclusion
- Subjects receiving a non-Genentech GH preparation
- Subjects with closed epiphyses
- Subjects with active neoplasia
- Current participation in another GH clinical study
- Current participation in the core study
Key Trial Info
Start Date :
March 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
395 Patients enrolled
Trial Details
Trial ID
NCT00097617
Start Date
March 1 2002
End Date
July 1 2010
Last Update
November 14 2012
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