Regional Kidney Paired Donor Exchange in Sensitized Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

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.

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Detailed Description

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Conditions

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The Rate of Kidney Transplants in Sensitized Patients.

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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%

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No