A Study in Children With Growth Failure Due to Chronic Renal Insufficiency (CRI) or End Stage Renal Disease (ESRD)

End-Stage Renal Disease Clinical Trial

Official title:

National Cooperative Growth Study (NCGS) of Nutropin AQ, Nutropin, and Protropin in Children With Growth Failure Due to Chronic Renal Insufficiency (CRI) or End Stage Renal Disease (ESRD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097617
• Other study ID #: 85-036, Substudy 11
• Status: Completed
• Phase: Phase 4
• First received: November 24, 2004
• Last updated: November 13, 2012
• Start date: March 2002
• Est. completion date: July 2010

Study information

• Verified date: November 2012
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 395
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Renal Insufficiency
• End-Stage Renal Disease
• Failure to Thrive
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.