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| Name | Class |
|---|---|
| Indiana University Health | OTHER |
| University of Miami | OTHER |
| MOUNT SINAI HOSPITAL | OTHER |
| University of Wisconsin, Madison |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hard-to-Place (HTP) Donor Kidneys | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sub-Normothermic Machine Preservation and Assessment | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 7-Day Delayed Graft Function (DGF) | Requirement for dialysis within first 7 days post-transplant | 7 days post-transplant |
| Graft Survival | Donor kidney survival |
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Donor Kidney Inclusion Criteria:
Donor Kidney Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Chris Jaynes | 34 Lives, PBC (Sponsor) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edward Hines, Jr. VA Hospital | Chicago | Illinois | 60141 | United States | ||
| Indiana University Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34212471 | Background | 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. | |
| 37231075 | Background | 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. |
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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.
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| OTHER |
| Erie County Medical Center, Buffalo, NY | UNKNOWN |
| Duke University Hospital, USA | UNKNOWN |
| Barnes-Jewish Hospital | OTHER |
| Edward Hines Jr. VA Hospital | FED |
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Sponsor will collect kidney perfusate and urine samples at 90- and 120-minutes during SNMP to store in a -80C specimen freezer for future analysis or quality assurance. Sponsor will collect a 4mm core punch biopsy at the superior pole of the kidney for research use. Research testing of samples may include cytokine, ATP, metabolomics, transcriptomics, proteomics, genomics, dynamic contrast imagery (DCI) and/or hematoxylin and eosin (H&E) histologic staining. All donor kidneys enrolled in this study will have legally authorized consent for organ donation for transplant and research purposes.
|
| 1- and 3-months post-transplant |
| Patient Survival | Recipient survival | 1- and 3-months post-transplant |
| Serum Creatinine (sCr) | Recipient sCr | 1- and 3-months post-transplant |
| eGFR | Recipient estimated glomerular filtration rate | 1- and 3-months post-transplant |
| Long term data collection- Graft Survival | Graft survival | Annually, up to 3-years post-transplant |
| Long term data collection- Patient Survival | Patient survival | Annually, up to 3-years post-transplant |
| Long term data collection- Serum Creatinine | Recipient sCr | Annually, up to 3-years post-transplant |
| Long term data collection- eGFR | Recipient estimated glomerular filtration rate | Annually, up to 3-years post-transplant |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Erie County Medical Center | Buffalo | New York | 14215 | United States |
| New York University Langone | New York | New York | 10016 | United States |
| The Mount Sinai Hospital | New York | New York | 10029 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | 53792 | United States |
| 31599063 | Background | 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. |
| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
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