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Regional Kidney Paired Donor Exchange in Sensitized Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01896089
Recruitment Status : Unknown
Verified August 2016 by BiologicTx, LLC.
Recruitment status was:  Recruiting
First Posted : July 11, 2013
Last Update Posted : September 2, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
The Rate of Kidney Transplants in Sensitized Patients.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
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 Start Date : December 2013
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. The rate of kidney transplant in sensitized patients following desensitization and enrollment in a regional kidney paired donor exchange program [ Time Frame: 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 :
  1. Overall number of kidney transplants per center/region [ Time Frame: 24 months ]
    To determine the overall number of kidney transplants per center/region.


Other Outcome Measures:
  1. The overall number of KPD matches in the region [ Time Frame: 24 months ]
  2. Donor types (direct, paired exchange, altruistic) [ Time Frame: 24 months ]
  3. The overall number of KPD exchange recipients transplanted in the region [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Approximately 250 renal transplant candidates at 6 transplantation centers in the United States (northwest) will participate.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896089


Locations
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United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Donald Rodriguez    206-342-6958    donald.rodriguez@vmmc.org   
Principal Investigator: Andrew Weiss, MD         
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Terri Spinelli    206-215-3063    terri.spinelli@swedish.org   
Principal Investigator: Lisa Florence, MD         
Sponsors and Collaborators
BiologicTx, LLC
Investigators
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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)
Additional Information:

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Responsible Party: BiologicTx, LLC
ClinicalTrials.gov Identifier: NCT01896089    
Other Study ID Numbers: KPD6172013
First Posted: July 11, 2013    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: August 2016