National Cooperative Growth Study in CKD | NCT00616278

Studies
National Cooperative Growth Study in CKD

NCT00616278

Sponsor

University of California, Davis

Status

Completed

Last Update Posted

May 30, 2017Actual

Enrollment

27Actual

Phase

Not provided

Conditions

Growth Hormone Deficiency

Interventions

Not provided

Countries

United States

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

May 2017

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

Oct 2005

Primary Completion Date

Feb 2010Actual

Completion Date

Feb 2010Actual

First Submitted Date

Feb 4, 2008

First Submission Date that Met QC Criteria

Feb 14, 2008

First Posted Date

Feb 15, 2008Estimated

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

May 25, 2017

Last Update Posted Date

May 30, 2017Actual

Name	Class
Genentech, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to learn whether growth hormone being administered to children with Chronic Kidney Disease is effective and if it has any side effects.

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

27Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary outcome measures of the NCGS are ongoing safety and efficacy of Genentech GH preparations in pediatric growth disorders for which GH is initiated.		per the study, the pt will be on GH treatement until the physician instructs them to stop

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be a patient of the UC Davis Medical Center pediatric clinic with Chronic Kidney Disease

Exclusion Criteria:

Greater than 18 years old
Not a patient at the UC Davis Medical Center pediatric clinic

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

pediatric clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lavjay Butani, M.D.	University of California, Davis	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UC Davis Medical Center		Sacramento	California	95817	United States

Condition Browse Module

MeSH Terms

ID	Term
D004393	Dwarfism, Pituitary
D051436	Renal Insufficiency, Chronic
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D004392	Dwarfism
D001848	Bone Diseases, Developmental
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided