A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation

Last updated: March 28, 2025
Sponsor: 34 Lives, PBC
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Organ Transplant

Treatment

Sub-Normothermic Machine Preservation and Assessment

Clinical Study ID

NCT06263023
34L-CP-02-009
  • Ages 16-75
  • All Genders

Study Summary

This is a study to collect information to assess if transporting hard-to-place (HTP) donor kidneys to a central preservation and assessment facility with dedicated organ assessment capabilities increases allocation success to transplant hospitals.

Eligibility Criteria

Inclusion

Donor Kidney Inclusion Criteria:

  • Be considered HTP, by receiving refusals from every transplant center within the 250nm allocation radius or similar definition by the local OPO.

  • From a Male or female deceased donor, aged 16- 75 years old.

  • Kidney initially procured, preserved, and packaged with intent to transplant.

  • LAP provides informed consent for organ donation for transplant and researchpurposes.

  • The HTP donor kidney must be allocated to a participating transplant center by aparticipating OPO, and the transplant center makes the decision to send kidney toSponsor's central preservation and assessment facility for SNMP assessment andpreservation prior to determining suitability for allocation.

Exclusion

Donor Kidney Exclusion Criteria:

  • From a Donor with pre-admission diagnosis of end stage renal failure.

  • Obvious surgical damage to artery(s), vein(s), or ureter(s) preventing machineperfusion.

  • From a donor with confirmed HIV (+), HBVSAg (+) and/or HCV NAT (+) serology results.

  • No LAP consent for both transplant and research purposes.

  • Cannot arrive to Sponsor's central preservation and assessment facility beforereaching 24 hours of cold ischemic time (CIT).

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Sub-Normothermic Machine Preservation and Assessment
Phase:
Study Start date:
April 19, 2024
Estimated Completion Date:
March 25, 2028

Study Description

This is an Observational study of a centralized kidney assessment facility providing brief sub-normothermic machine perfusion (SNMP) to HTP donor kidneys to provide transplant centers additional information for accepting HTP kidneys.

This study is intended to collect data to evaluate the feasibility of a dedicated central service to determine if additional assessment data helps increase allocation to transplant centers. Transplantation will follow standard-of-care at each transplant center, including required post-transplant data collection, which must be reported to the OPTN registry by the center.

Connect with a study center

  • Miami Transplant Institute, University of Miami Miller School of Medicine

    Miami, Florida 33136
    United States

    Site Not Available

  • Edward Hines, Jr. VA Hospital

    Chicago, Illinois 60141
    United States

    Site Not Available

  • Indiana University Health

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Barnes-Jewish Hospital

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Erie County Medical Center

    Buffalo, New York 14215
    United States

    Site Not Available

  • New York University Langone

    New York, New York 10016
    United States

    Site Not Available

  • The Mount Sinai Hospital

    New York, New York 10029
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27710
    United States

    Site Not Available

  • University of Wisconsin School of Medicine and Public Health

    Madison, Wisconsin 53792
    United States

    Site Not Available

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