Regional Kidney Paired Donor Exchange in Sensitized Patients

• Conditions: The Rate of Kidney Transplants in Sensitized Patients.

• Registration Number: NCT01896089
• Lead Sponsor: BiologicTx, LLC

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 rate of kidney transplantation in sensitized patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-28
• Study First Submitted QC: 2013-07-08
• Study First Posted: 2013-07-11
• Study Start: 2013-12
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-31
• Last Update Posted: 2016-09-02
• Primary Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• A. Potential Recipients must meet the following 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%

B. Potential Living Donors must meet the following inclusion criteria:

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of kidney transplant in sensitized patients following desensitization and enrollment in a regional kidney paired donor exchange program	24 months	The rate of kidney transplant in sensitized patients following desensitization and enrollment in a regional kidney paired donor exchange program will be summarized.

Secondary Outcome Measures

Name	Time	Method
Overall number of kidney transplants per center/region	24 months	To determine the overall number of kidney transplants per center/region.

Trial Locations

Locations (2)

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States