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A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation

NCT06263023 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2025-04-02

No results posted yet for this 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.

Conditions

  • Organ Preservation

Interventions

OTHER

Sub-Normothermic Machine Preservation and Assessment

Human kidneys from HTP deceased donors will be transported to the Sponsor's central preservation and assessment facility and placed onto a machine perfusion system in a sterile operating room for a brief period of Sub-Normothermic Machine Perfusion (SNMP). Basic parameters including internal renal resistance, oxygen, and electrolyte levels will be recorded using standard point-of-care hospital analyzers. Accepted kidneys will be transported to a participating transplant center using a portable oxygenated LifePort Hypothermic Machine Preservation (HMP) device.

Sponsors & Collaborators

  • Indiana University Health

    collaborator OTHER

  • University of Miami

    collaborator OTHER

  • MOUNT SINAI HOSPITAL

    collaborator OTHER

  • University of Wisconsin, Madison

    collaborator OTHER

  • Erie County Medical Center, Buffalo, NY

    collaborator UNKNOWN

  • Duke University Hospital, USA

    collaborator UNKNOWN

  • Barnes-Jewish Hospital

    collaborator OTHER

  • Edward Hines Jr. VA Hospital

    collaborator FED

  • 34 Lives, PBC

    lead INDUSTRY

Principal Investigators

  • Chris Jaynes · 34 Lives, PBC (Sponsor)

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-19
Primary Completion
2025-03-25
Completion
2028-03-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06263023 on ClinicalTrials.gov