A Study in Children With Growth Failure Due to Chronic Renal Insufficiency (CRI) or End Stage Renal Disease (ESRD)
Completed
- Conditions
- End-Stage Renal DiseaseChronic Renal Insufficiency
- Registration Number
- NCT00097617
- Lead Sponsor
- Genentech, Inc.
- 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 CRI in the United States.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 395
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method