Regional Kidney Paired Donor Exchange in Sensitized Patients

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.

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98101
      • Recruiting
      • Virginia Mason Medical Center
      • Contact: Donald Rodriguez; Phone Number: 206-342-6958; Email: donald.rodriguez@vmmc.org
      • Principal Investigator: Andrew Weiss, MD
    • Seattle, Washington, United States, 98104
      • Recruiting
      • Swedish Medical Center
      • Contact: Terri Spinelli; Phone Number: 206-215-3063; Email: terri.spinelli@swedish.org
      • Principal Investigator: Lisa Florence, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Approximately 250 renal transplant candidates at 6 transplantation centers in the United States (northwest) will participate.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
The overall number of KPD matches in the region	24 months
Donor types (direct, paired exchange, altruistic)	24 months
The overall number of KPD exchange recipients transplanted in the region	24 months

Collaborators and Investigators

• Sponsor: BiologicTx, LLC
• Investigators: Principal Investigator: Lisa Florence, MD, Swedish Medical Center; Principal Investigator: Andrew Weiss, MD, Virginia Mason Medical Center; Principal Investigator: Douglas Norman, MD, Oregon Health and Science University; Principal Investigator: Richard Carson, MD, Sacred Heart Medical Center (Spokane)

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: June 28, 2013
• First Submitted That Met QC Criteria: July 8, 2013
• First Posted (Estimate): July 11, 2013

Study Record Updates

• Last Update Posted (Estimate): September 2, 2016
• Last Update Submitted That Met QC Criteria: August 31, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: KPD6172013