Regional Kidney Paired Donor Exchange in Sensitized Patients

Prospective, Multicenter, Observational Registry Study to Determine if Enrollment in a Regional Kidney Paired Donor Exchange Program Improves the Overall Rate of Kidney Transplantation in Sensitized Patients, and Sensitized Patients Undergoing Desensitization Treatments.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01896089

Enrollment

100

Registered

2013-07-11

Start date

2013-12-31

Completion date

Unknown

Last updated

2016-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The Rate of Kidney Transplants in Sensitized Patients.

Brief summary

This is a prospective, multi-center, observational study to determine if a combination of desensitization and enrollment in a regional kidney paired donor (KPD) exchange program improves the overall rate of kidney transplantation in sensitized patients.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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: 1. Must provide informed consent in accordance with the process outlined in the Informed Consent Requirements Section of the KPD Program Manual of Operations 2. Must be at least 18 years old 3. Meet all living donor selection criteria of the transplant center 4. 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 1. Unwilling or unable to provide informed consent 2. Have identified barriers to donation as set forth in the Living Donor Evaluation Section of the KPD Program Manual of Operations (Appendix A) 3. Must not be currently listed as a potential living donor for any other recipient registered in the KPD system 4. Pregnant or breast feeding

Design outcomes

Primary

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

Secondary

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

Other

Measure	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	24 months

Countries

United States

Outcome results