A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation
- Conditions
- Organ Preservation
- Interventions
- Other: Sub-Normothermic Machine Preservation and Assessment
- Registration Number
- NCT06263023
- Lead Sponsor
- 34 Lives, PBC
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- Be considered HTP, by receiving refusals from every transplant center within the 250 nm 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 research purposes.
- The HTP donor kidney must be allocated to a participating transplant center by a participating OPO, and the transplant center makes the decision to send kidney to Sponsor's central preservation and assessment facility for SNMP assessment and preservation prior to determining suitability for allocation.
Donor Kidney
- From a Donor with pre-admission diagnosis of end stage renal failure.
- Obvious surgical damage to artery(s), vein(s), or ureter(s) preventing machine perfusion.
- 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 before reaching 24 hours of cold ischemic time (CIT).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Hard-to-Place (HTP) Donor Kidneys Sub-Normothermic Machine Preservation and Assessment 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.
- Primary Outcome Measures
Name Time Method Transplant Allocation Success 1 year 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.
- Secondary Outcome Measures
Name Time Method Long term data collection- eGFR Annually, up to 3-years post-transplant Recipient estimated glomerular filtration rate
Graft Survival 1- and 3-months post-transplant Donor kidney survival
Long term data collection- Graft Survival Annually, up to 3-years post-transplant Graft survival
Long term data collection- Patient Survival Annually, up to 3-years post-transplant Patient survival
Long term data collection- Serum Creatinine Annually, up to 3-years post-transplant Recipient sCr
7-Day Delayed Graft Function (DGF) 7 days post-transplant Requirement for dialysis within first 7 days post-transplant
Patient Survival 1- and 3-months post-transplant Recipient survival
Serum Creatinine (sCr) 1- and 3-months post-transplant Recipient sCr
eGFR 1- and 3-months post-transplant Recipient estimated glomerular filtration rate
Trial Locations
- Locations (8)
New York University Langone
🇺🇸New York, New York, United States
Duke University
🇺🇸Durham, North Carolina, United States
University of Wisconsin School of Medicine and Public Health
🇺🇸Madison, Wisconsin, United States
Edward Hines, Jr. VA Hospital
🇺🇸Chicago, Illinois, United States
Indiana University Health
🇺🇸Indianapolis, Indiana, United States
Barnes-Jewish Hospital
🇺🇸St. Louis, Missouri, United States
The Mount Sinai Hospital
🇺🇸New York, New York, United States
Erie County Medical Center
🇺🇸Buffalo, New York, United States