An observational study in Organ Preservation, sponsored by 34 Lives, PBC. Active, not recruiting at 8 sites in United States. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-02.
Sponsored by 34 Lives, PBC · Observational
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.
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.
This is the only study on the registry with 34 Lives, PBC as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The study population includes hard-to-place (HTP) deceased donor kidneys retrieved from donation after brain death (DBD) and donation after circulatory death (DCD) donors aged 16- 75.
Donor Kidney Inclusion Criteria:
Donor Kidney Exclusion Criteria:
The study will be open to all eligible HTP kidneys from male and female donors at all participating Organ Procurement Organization (OPO) study sites. Consent for both organ donation for transplant and medical research will be obtained from the legally authorized party (LAP) by the OPO Coordinator using industry standard consent procedures and documents.
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.
Transplant Allocation Success
The primary objective for this study is a 50% success rate or higher for allocation of Hard-to-Place (HTP) kidneys to a participating transplant center after sNMP assessment at the Sponsor's central facility.
Time frame: 1 year
7-Day Delayed Graft Function (DGF)
Requirement for dialysis within first 7 days post-transplant
Time frame: 7 days post-transplant
Graft Survival
Donor kidney survival
Time frame: 1- and 3-months post-transplant
Patient Survival
Recipient survival
Time frame: 1- and 3-months post-transplant
Serum Creatinine (sCr)
Recipient sCr
Time frame: 1- and 3-months post-transplant
eGFR
Recipient estimated glomerular filtration rate
Time frame: 1- and 3-months post-transplant
Long term data collection- Graft Survival
Graft survival
Time frame: Annually, up to 3-years post-transplant
Long term data collection- Patient Survival
Patient survival
Time frame: Annually, up to 3-years post-transplant
Long term data collection- Serum Creatinine
Recipient sCr
Time frame: Annually, up to 3-years post-transplant
Long term data collection- eGFR
Recipient estimated glomerular filtration rate
Time frame: Annually, up to 3-years post-transplant
Plan to share: No — Standard data will be obtained from the Organ Procurement and Transplantation Network (OPTN), which is readily available to the public via request to the Health Resources Service Administration (HRSA), in de-identified form to protect privacy. These standard data include information about the organ donor, preservation procedure, the recipient's kidney transplant, and post-operative follow-up.
This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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