Regional Kidney Paired Donor Exchange in Sensitized Patients

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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The Rate of Kidney Transplants in Sensitized Patients.

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: C. 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 |