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

Genentech, Inc.395 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

395

Conditions

Chronic Renal Insufficiency End-Stage Renal Disease

Eligibility

Sex: ALLMax age: 17 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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