Regional Kidney Paired Donor Exchange in Sensitized Patients

BiologicTx

Status: Unknown

Conditions: The Rate of Kidney Transplants in Sensitized Patients.

Study type: Observational

Funder types: Industry

Identifiers

NCT01896089

KPD6172013

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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