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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