Regional Kidney Paired Donor Exchange in Sensitized Patients
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ClinicalTrials.gov Identifier: NCT01896089
Recruitment Status : Unknown
Verified August 2016 by BiologicTx, LLC. Recruitment status was: Recruiting
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.
Condition or disease
The Rate of Kidney Transplants 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.
Study Start Date :
Estimated Primary Completion Date :
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Approximately 250 renal transplant candidates at 6 transplantation centers in the United States (northwest) will participate.
A. 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%
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
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
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