Regional Kidney Paired Donor Exchange in Sensitized Patients | NCT01896089

Studies
Regional Kidney Paired Donor Exchange in Sensitized Patients

NCT01896089

Sponsor

BiologicTx, LLC

Status

Unknown status

Last Update Posted

Sep 2, 2016Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

The Rate of Kidney Transplants in Sensitized Patients.

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

Aug 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Dec 2018Estimated

Completion Date

Not provided

First Submitted Date

Jun 28, 2013

First Submission Date that Met QC Criteria

Jul 8, 2013

First Posted Date

Jul 11, 2013Estimated

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

Aug 31, 2016

Last Update Posted Date

Sep 2, 2016Estimated

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The rate of kidney transplant in sensitized patients following desensitization and enrollment in a regional kidney paired donor exchange program	The rate of kidney transplant in sensitized patients following desensitization and enrollment in a regional kidney paired donor exchange program will be summarized.	24 months

Secondary Outcomes

Measure	Description	Time Frame
Overall number of kidney transplants per center/region	To determine the overall number of kidney transplants per center/region.	24 months

Other Outcomes

Measure	Description	Time Frame
The overall number of KPD matches in the region		24 months
Donor types (direct, paired exchange, altruistic)		24 months
The overall number of KPD exchange recipients transplanted in the region

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A. Potential Recipients must meet the following inclusion criteria:
1. Willing and able to sign an informed consent form
2. Must be at least 18 years old
3. Meet all recipient selection criteria of the transplant center
4. Listed on the deceased donor kidney waiting list for renal transplant at a participating center
5. Potential recipients must:

Group 1: have one or more medically suitable donors who are ABO incompatible or HLA incompatible (defined as positive serologic cross-match); or

Group 2: have a medically suitable donor that is otherwise deemed incompatible due to age, size, or other mismatch by their respective transplant center; or

Group 3: be listed on the deceased donor waiting list for ≥ one year without an identifiable living donor and have a PRA% ≥ 60%

B. Potential Living Donors must meet the following inclusion criteria:

Must provide informed consent in accordance with the process outlined in the Informed Consent Requirements Section of the KPD Program Manual of Operations
Must be at least 18 years old
Meet all living donor selection criteria of the transplant center
Meet the evaluation requirements set forth in the Living Donor Evaluation Section of the KPD Program Operational Guidelines

Exclusion Criteria:

C. Recipients
1. Do not meet selection criteria of the transplant center
2. Eligible compatible donor at the time of enrollment
3. Inactive (not eligible to receive a kidney) on the deceased donor waitlist
4. Pregnant or breast feeding

D. Donors

Unwilling or unable to provide informed consent
Have identified barriers to donation as set forth in the Living Donor Evaluation Section of the KPD Program Manual of Operations (Appendix A)
Must not be currently listed as a potential living donor for any other recipient registered in the KPD system
Pregnant or breast feeding

Accepts Healthy Volunteers

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

Approximately 250 renal transplant candidates at 6 transplantation centers in the United States (northwest) will participate.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Lisa Florence, MD	Swedish Medical Center	Principal Investigator
Andrew Weiss, MD	Virginia Mason Medical Center	Principal Investigator
Douglas Norman, MD	Oregon Health and Science University	Principal Investigator
Richard Carson, MD	Sacred Heart Medical Center (Spokane)	Principal Investigator