Recruiting

Kidney Exchange

Sponsor:

BiologicTx, LLC

Code:

NCT01896089

Conditions

The Rate of Kidney Transplants in Sensitized Patients.

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

The Rate of Kidney Transplants in Sensitized Patients.

Study ID

NCT01896089

Start date

Dec, 2013

Status verified date

Aug, 2016

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • The rate of kidney transplant in sensitized patients following desensitization and enrollment in a regional kidney paired donor exchange program [ Time Frame: 24 months ]

Central Contacts and Locations

Locations

Virginia Mason Medical Center

Recruiting

Seattle, Washington, United States, 98101

Contacts

Principal Investigator:

Andrew Weiss, MD

Swedish Medical Center

Recruiting

Seattle, Washington, United States, 98104

Contacts

Principal Investigator:

Lisa Florence, MD

More Information

Sponsor

BiologicTx, LLC

Last update posted

Sep 2, 2016

Last verified

Aug, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by BiologicTx, LLC on 2016-09-02.