NCT00097617

Completed

A Study in Children With Growth Failure Due to Chronic Renal...

Genentech, Inc.Source

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Other study identifiers

Sponsor study identifier

85-036, Substudy 11

Study Type

observational

Actual enrollment (reported)

395

Locations

0 countries

Sites

N/A

Timeline

Study Start

March 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

July 2010

Actual (reported)

Study Completion

July 2010

Actual (reported)

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 CRI in the United States.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 395 participants
Study completion date: July 2010
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2002
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
November 24, 2004
Actual (reported)
First Posted
November 25, 2004
Actual (reported)
Primary Completion
July 2010
Actual (reported)
Study Completion
July 2010
Actual (reported)

Last Updated: November 14, 2012
Status Verified: November 2012
Last Update Submitted: November 13, 2012

Conditions

Chronic Renal Insufficiency End-Stage Renal Disease

Eligibility Criteria

AgeUp to 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

Sampling MethodNon-Probability Sample

Study Population

primary care clinic

You may qualify if:

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

You may not qualify if:

Subjects receiving a non-Genentech GH preparation

Sponsors & Collaborators

Genentech, Inc.
Industrylead

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Barbara Lippe, M.D.
Genentech, Inc.
STUDY DIRECTOR

Enrollment

395 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 24, 2004

First Posted

November 25, 2004

Study Start

March 2002

Date type not reported

This date has not been verified as actual or estimated.

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Subjects with closed epiphyses

Subjects with active neoplasia

Current participation in another GH clinical study

Current participation in the core study

Contact the study team to confirm eligibility.

Primary Completion

July 2010

Actual (reported)

Study Completion

July 2010

Actual (reported)

Last Updated

November 14, 2012

Record last verified: 2012-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00097617
Data provider: ClinicalTrials.gov
Source updated: 2012-11-14
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:39 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record