protocolSection identificationModule nctId: NCT06280950, orgStudyIdInfo id: DAIT CTOT-43, briefTitle: Expanding Liver Transplant Immunosuppression Minimization Via Everolimus, acronym: ELIMINATE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2027-06-01, completionDateStruct date: 2029-06-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: National Institute of Allergy and Infectious Diseases (NIAID), class: NIH, descriptionModule briefSummary: This is a study to determine the safety, efficacy, and tolerability of taking away the anti-rejection medicine, tacrolimus, in liver transplant recipients in conjunction with everolimus monotherapy to preserve renal function. Two hundred - seventy (270) subjects will be randomized 2:1 into one of two groups between 2-3 months post-transplant. Seventy participants will be placed into an observational group and will remain on their current post-transplant medications. The duration of the study from time of enrollment is 18-20 months., conditionsModule conditions: Liver Transplant, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 340, type: ESTIMATED, armsInterventionsModule interventions name: Everolimus, interventions name: Tacrolimus (continued reduction), interventions name: Tacrolimus (maintain 50% reduction), interventions name: Everolimus, outcomesModule primaryOutcomes measure: Percent change in estimated glomerular filtration rate (eGFR) by CKD-EPI 2021 equation. Between Cohorts INT-1 and INT-2, primaryOutcomes measure: Proportion of subjects with treated Biopsy Proven Acute Rejection (tBPAR) per local pathology. Between cohorts INT-1 and INT-2, secondaryOutcomes measure: Percent change in Estimated Glomerular Filtration Rate (eGFR) in Renal function, secondaryOutcomes measure: Percentage of subjects with treated Biopsy Proven Acute Rejection (tBPAR) in Liver Function, secondaryOutcomes measure: Changes in liver graft function: Total bilirubin, secondaryOutcomes measure: Changes in liver graft function: Direct bilirubin, secondaryOutcomes measure: Changes in liver graft function: Alanine Aminotransaminase (ALT), secondaryOutcomes measure: Changes in liver graft function: Aspartate Aminotransferase (AST), secondaryOutcomes measure: Changes in liver graft function: Alkaline Phosphatase, secondaryOutcomes measure: Time to graft failure in liver function defined as relisting for transplantation, re-transplantation itself or death with failed graft, secondaryOutcomes measure: Time to all-cause mortality, secondaryOutcomes measure: Proportion of subjects experiencing a Major Adverse Cardiac Event (MACE), secondaryOutcomes measure: Proportion of subjects experiencing infection requiring hospitalization, secondaryOutcomes measure: Proportion of subjects experiencing any malignancy, secondaryOutcomes measure: Proportion of subjects developing severe Estimated Glomerular Filtration Rate (eGFR) deterioration >40 percent from baseline using the CKD-EPI 2021 equation, secondaryOutcomes measure: Proportion of subjects developing any major immunosuppressive therapy complications, secondaryOutcomes measure: Proportion of subjects developing new onset peripheral edema, secondaryOutcomes measure: Proportion of subjects developing new onset cytopenia deemed WBC <3.0x10^9 /L, Hb <8.0 g/dL, or platelets <50 x 10^9/L., secondaryOutcomes measure: Proportion of subjects developing new onset oral/gastrointestinal ulcerations, secondaryOutcomes measure: Proportion of subjects developing new onset gastrointestinal symptoms (nausea, vomiting, abdominal pain, or diarrhea) related to everolimus therapy., secondaryOutcomes measure: Proportion of subjects developing new onset pneumonitis, secondaryOutcomes measure: Proportion of subjects developing new onset hepatic artery thrombosis, secondaryOutcomes measure: Proportion of subjects developing other adverse events deemed, secondaryOutcomes measure: Proportion of subjects developing any adverse events related to everolimus therapy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic Hospital Arizona (Site #: 71144), city: Phoenix, state: Arizona, zip: 85054, country: United States, contacts name: Hugo Vargas, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.44838, lon: -112.07404, locations facility: University of California, San Francisco (Site #: 71108), city: San Francisco, state: California, zip: 94143, country: United States, contacts name: Joanna Kwan, role: CONTACT, phone: 415-476-2574, email: joanne.kwan@ucsf.edu, contacts name: Sandy Feng, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Northwestern University (Site #: 71110), city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Dania Jahangir, role: CONTACT, email: dania.jahangir@northwestern.edu, contacts name: Justin Boike, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Icahn School of Medicine at Mount Sinai (Site #: 71115), city: New York, state: New York, zip: 10029, country: United States, contacts name: Bharathi Ramesh, role: CONTACT, email: Bharathi.ramesh@mountsinai.org, contacts name: Thomas Schiano, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Duke University Medical Center (Site #: 71139), city: Durham, state: North Carolina, zip: 27710, country: United States, contacts name: Linda Perry, role: CONTACT, email: linda.perry@duke.edu, contacts name: Carl Berg, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.99403, lon: -78.89862, locations facility: University of Pennsylvania (Site #: 71111), city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Lexi Tumblety, role: CONTACT, phone: 267-441-1800, email: lexi.tumblety@pennmedicine.upenn.edu, contacts name: Abraham Shaked, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, locations facility: University of Pittsburgh Medical Center (Site #: 71162), city: Pittsburgh, state: Pennsylvania, zip: 15260, country: United States, contacts name: Lois Kipling, role: CONTACT, email: kniplingle@upmc.edu, contacts name: Scott Biggins, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, locations facility: Baylor Medical Center (Site #: 71153), city: Dallas, state: Texas, zip: 75246, country: United States, contacts name: Angela Roy, role: CONTACT, email: angela.roy@baylorhealth.edu, contacts name: Sumeet Asrani, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False