Status:
UNKNOWN
Regional Kidney Paired Donor Exchange in Sensitized Patients
Lead Sponsor:
BiologicTx, LLC
Conditions:
The Rate of Kidney Transplants in Sensitized Patients.
Eligibility:
All Genders
18+ years
Brief Summary
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01896089
Start Date
December 1 2013
Last Update
September 2 2016
Active Locations (2)
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1
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
2
Swedish Medical Center
Seattle, Washington, United States, 98104