protocolSection identificationModule nctId: NCT06263023, orgStudyIdInfo id: 34L-CP-02-009, briefTitle: A Central Preservation and Assessment Service to Optimize Donor Kidney Allocation, acronym: OPTIMAL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-19, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: 34 Lives, PBC, class: INDUSTRY, collaborators name: Indiana University Health, collaborators name: University of Miami, collaborators name: MOUNT SINAI HOSPITAL, collaborators name: University of Wisconsin, Madison, descriptionModule briefSummary: 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., conditionsModule conditions: Organ Preservation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Sub-Normothermic Machine Preservation and Assessment, outcomesModule primaryOutcomes measure: Transplant Allocation Success, secondaryOutcomes measure: 7-Day Delayed Graft Function (DGF), secondaryOutcomes measure: Graft Survival, secondaryOutcomes measure: Patient Survival, secondaryOutcomes measure: Serum Creatinine (sCr), secondaryOutcomes measure: eGFR, secondaryOutcomes measure: Long term data collection- Graft Survival, secondaryOutcomes measure: Long term data collection- Patient Survival, secondaryOutcomes measure: Long term data collection- Serum Creatinine, secondaryOutcomes measure: Long term data collection- eGFR, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 75 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Miami Transplant Institute, University of Miami Miller School of Medicine, status: NOT_YET_RECRUITING, city: Miami, state: Florida, zip: 33136, country: United States, contacts name: Giselle Guerra, MD, role: CONTACT, contacts name: Giselle Guerra, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Indiana University Health, status: RECRUITING, city: Indianapolis, state: Indiana, zip: 46202, country: United States, contacts name: William Goggins, MD, role: CONTACT, contacts name: William Goggins, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.76838, lon: -86.15804, locations facility: The Mount Sinai Hospital, status: RECRUITING, city: New York, state: New York, zip: 10029, country: United States, contacts name: Matthew Holzner, MD, role: CONTACT, contacts name: Matthew Holzner, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: University of Wisconsin School of Medicine and Public Health, status: NOT_YET_RECRUITING, city: Madison, state: Wisconsin, zip: 53792, country: United States, contacts name: Jacqueline Garonzik Wang, MD, role: CONTACT, contacts name: Jacqueline Garonzik Wang, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False