Transplant Patient Registry of Liver, Kidney and/or Pancreas | NCT00238693

Studies
Transplant Patient Registry of Liver, Kidney and/or Pancreas

NCT00238693

Sponsor

Virginia Commonwealth University

Status

Completed

Last Update Posted

Sep 25, 2018Actual

Enrollment

13,767Actual

Phase

Not provided

Conditions

End Stage Renal Disease
End Stage Liver Disease

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

Sep 2018

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

Apr 2003

Primary Completion Date

Aug 27, 2018Actual

Completion Date

Aug 27, 2018Actual

First Submitted Date

Oct 11, 2005

First Submission Date that Met QC Criteria

Oct 11, 2005

First Posted Date

Oct 13, 2005Estimated

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

Sep 24, 2018

Last Update Posted Date

Sep 25, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

This is a registry of data collected from patient records, both of those who have a condition which may require transplantation and those who have undergone transplantation of the liver, kidney and/or pancreas.

Detailed Description

Honest Broker arrangement.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

13,767Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Data collection and maintenance	MAINTAIN A CURRENT, ACCURATE DATA BASE OF TRANSPLANT RECIPIENTS WITH REGARDS TO TRANSPLANT DATA AND OUTCOMES.	Ongoing

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients followed in the transplant clinic at Virginia Commonwealth University Health System

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients followed in the transplant clinic at Virginia Commonwealth University Health System

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adrian H Cotterell, MD, FACS	Virginia Commonwealth University Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Commonwealth University Health System		Richmond	Virginia	23298	United States

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic
D058625	End Stage Liver Disease

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided