Clinical trial NCT06263023: A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation
Official title: An Observational Study of a Dedicated Preservation and Assessment Service to Optimize Organ Utilization for Hard-to-Place Kidneys
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Organ Preservation
Keywords: SNMP
Preservation
Transplantation
Kidney
Lead sponsor: 34 Lives, PBC
Sponsor class: INDUSTRY
Collaborators: name: Indiana University Health
name: University of Miami
name: MOUNT SINAI HOSPITAL
name: University of Wisconsin, Madison
name: Erie County Medical Center, Buffalo, NY
name: Duke University Hospital, USA
name: Barnes-Jewish Hospital
name: Edward Hines Jr. VA Hospital
First posted: 2024-02-16
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Donor Kidney Inclusion Criteria:

* 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 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 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).

Primary outcomes:
measure: Transplant Allocation Success
timeFrame: 1 year
Secondary outcomes:
measure: 7-Day Delayed Graft Function (DGF)
timeFrame: 7 days post-transplant
measure: Graft Survival
timeFrame: 1- and 3-months post-transplant
measure: Patient Survival
timeFrame: 1- and 3-months post-transplant
measure: Serum Creatinine (sCr)
timeFrame: 1- and 3-months post-transplant
measure: eGFR
timeFrame: 1- and 3-months post-transplant
measure: Long term data collection- Graft Survival
timeFrame: Annually, up to 3-years post-transplant
measure: Long term data collection- Patient Survival
timeFrame: Annually, up to 3-years post-transplant
measure: Long term data collection- Serum Creatinine
timeFrame: Annually, up to 3-years post-transplant
measure: Long term data collection- eGFR
timeFrame: Annually, up to 3-years post-transplant
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Edward Hines, Jr. VA Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: St. Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Buffalo
country: United States
facility: Erie County Medical Center
state: New York
city: New York
country: United States
facility: New York University Langone
state: New York
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: 34 Lives, PBC (Sponsor)
name: Chris Jaynes
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kayler LK, Nie J, Noyes K. Hardest-to-place kidney transplant outcomes in the United States. Am J Transplant. 2021 Nov;21(11):3663-3672. doi: 10.1111/ajt.16739. Epub 2021 Jul 20.
citation: Hosgood SA, Callaghan CJ, Wilson CH, Smith L, Mullings J, Mehew J, Oniscu GC, Phillips BL, Bates L, Nicholson ML. Normothermic machine perfusion versus static cold storage in donation after circulatory death kidney transplantation: a randomized controlled trial. Nat Med. 2023 Jun;29(6):1511-1519. doi: 10.1038/s41591-023-02376-7. Epub 2023 May 25.
citation: Minor T, von Horn C, Gallinat A, Kaths M, Kribben A, Treckmann J, Paul A. First-in-man controlled rewarming and normothermic perfusion with cell-free solution of a kidney prior to transplantation. Am J Transplant. 2020 Apr;20(4):1192-1195. doi: 10.1111/ajt.15647. Epub 2019 Nov 10.