SHS_225036 FLOL CBTX 13088

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

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.

Inclusion Criteria:

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

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:

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

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
N/A
NCT01896089
All Other
Kidney Transplant
Lisa Florence, M.D.
Biologix TX
Julie Wallick
  • Swedish Medical Center