Clinical trial NCT01896089: Regional Kidney Paired Donor Exchange in Sensitized Patients
Official title: 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: The Rate of Kidney Transplants in Sensitized Patients.
Lead sponsor: BiologicTx, LLC
Sponsor class: INDUSTRY
First posted: 2013-07-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 250 renal transplant candidates at 6 transplantation centers in the United States (northwest) will participate.

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.


Eligibility criteria: 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

Primary outcomes:
measure: The rate of kidney transplant in sensitized patients following desensitization and enrollment in a regional kidney paired donor exchange program
timeFrame: 24 months
Secondary outcomes:
measure: Overall number of kidney transplants per center/region
timeFrame: 24 months
Other outcomes:
measure: The overall number of KPD matches in the region
timeFrame: 24 months
measure: Donor types (direct, paired exchange, altruistic)
timeFrame: 24 months
measure: The overall number of KPD exchange recipients transplanted in the region
timeFrame: 24 months
Locations:
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Swedish Medical Center
name: Lisa Florence, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Mason Medical Center
name: Andrew Weiss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Douglas Norman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sacred Heart Medical Center (Spokane)
name: Richard Carson, MD
role: PRINCIPAL_INVESTIGATOR
References: