The Paired Donation Consortium Paired Donation Program | NCT00374400

Studies
The Paired Donation Consortium Paired Donation Program

NCT00374400

Sponsor

University of Cincinnati

Status

Completed

Last Update Posted

Jan 3, 2008Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Kidney Transplant

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

Dec 2007

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

Sep 2004

Primary Completion Date

Not provided

Completion Date

Nov 2007Actual

First Submitted Date

Sep 8, 2006

First Submission Date that Met QC Criteria

Sep 8, 2006

First Posted Date

Sep 11, 2006Estimated

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

Dec 20, 2007

Last Update Posted Date

Jan 3, 2008Estimated

Name	Class
The Paired Donation Consortium	OTHER

Description Module

Brief Summary

The purpose of the protocol is to increase the number of living donor transplants by eliminating immune incompatibilities between donors and recipients through paired donation.

Detailed Description

The purpose of the protocol is to increase the number of living donor transplants by eliminating immune incompatibilities between donors and recipients through paired donation.

To increase the number of patients transplanted by paired donation by establishment of regional paired donation programs.

To develop educational programs for potential living donors and their recipient, as well as the opportunity for transplant professionals to increase acceptance of the PDC to maximize the opportunity for organ donation.

To identify and evaluate ethical and psychological factors that may influence the effects of paired donation on living kidney donation.

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

100Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Persons capable of providing written informed consent.
Each recipient must have one or more medically suitable donors who are either ABO-incompatible or HLA-incompatible.

Exclusion Criteria:

Persons with eligible, compatible donor.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steve Woodle, MD	University of Cincinnati	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Christ Hospital		Cincinnati	Ohio	45267	United States
University of Cincinnati