A Study in Children With Growth Failure Due to Chronic Re... | NCT00097617

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

NCT00097617

Sponsor

Genentech, Inc.

Status

Completed

Last Update Posted

Nov 14, 2012Estimated

Enrollment

395Actual

Phase

Not provided

Conditions

Chronic Renal Insufficiency
End-Stage Renal Disease

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2002

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Nov 24, 2004

First Submission Date that Met QC Criteria

Nov 24, 2004

First Posted Date

Nov 25, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2012

Last Update Posted Date

Nov 14, 2012Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

395Actual

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

17 Years

Standard Ages

Child

Study Population

primary care clinic

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Barbara Lippe, M.D.	Genentech, Inc.	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided