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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

395 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-03-31

Study Completion Date

2010-07-31

Brief Summary

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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

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Conditions

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Chronic Renal Insufficiency End-Stage Renal Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barbara Lippe, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Countries

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United States

Other Identifiers

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85-036, Substudy 11

Identifier Type: -

Identifier Source: org_study_id