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

Genentech

Status: Completed

Conditions: End-Stage Renal Disease; Chronic Renal Insufficiency

Study type: Observational

Funder types: Industry

Identifiers

NCT00097617

85-036, Substudy 11

Details and patient eligibility

About

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.

Enrollment: 395 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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