nctId: NCT06280950 id: DAIT CTOT-43 briefTitle: Expanding Liver Transplant Immunosuppression Minimization Via Everolimus acronym: ELIMINATE overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2027-06-01 date: 2029-06-01 date: 2024-02-28 date: 2024-02-28 name: National Institute of Allergy and Infectious Diseases (NIAID) class: NIH 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. conditions: Liver Transplant studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 340 type: ESTIMATED name: Everolimus name: Tacrolimus (continued reduction) name: Tacrolimus (maintain 50% reduction) name: Everolimus measure: Percent change in estimated glomerular filtration rate (eGFR) by CKD-EPI 2021 equation. Between Cohorts INT-1 and INT-2 measure: Proportion of subjects with treated Biopsy Proven Acute Rejection (tBPAR) per local pathology. Between cohorts INT-1 and INT-2 measure: Percent change in Estimated Glomerular Filtration Rate (eGFR) in Renal function measure: Percentage of subjects with treated Biopsy Proven Acute Rejection (tBPAR) in Liver Function measure: Changes in liver graft function: Total bilirubin measure: Changes in liver graft function: Direct bilirubin measure: Changes in liver graft function: Alanine Aminotransaminase (ALT) measure: Changes in liver graft function: Aspartate Aminotransferase (AST) measure: Changes in liver graft function: Alkaline Phosphatase measure: Time to graft failure in liver function defined as relisting for transplantation, re-transplantation itself or death with failed graft measure: Time to all-cause mortality measure: Proportion of subjects experiencing a Major Adverse Cardiac Event (MACE) measure: Proportion of subjects experiencing infection requiring hospitalization measure: Proportion of subjects experiencing any malignancy measure: Proportion of subjects developing severe Estimated Glomerular Filtration Rate (eGFR) deterioration >40 percent from baseline using the CKD-EPI 2021 equation measure: Proportion of subjects developing any major immunosuppressive therapy complications measure: Proportion of subjects developing new onset peripheral edema 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. measure: Proportion of subjects developing new onset oral/gastrointestinal ulcerations measure: Proportion of subjects developing new onset gastrointestinal symptoms (nausea, vomiting, abdominal pain, or diarrhea) related to everolimus therapy. measure: Proportion of subjects developing new onset pneumonitis measure: Proportion of subjects developing new onset hepatic artery thrombosis measure: Proportion of subjects developing other adverse events deemed measure: Proportion of subjects developing any adverse events related to everolimus therapy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic Hospital Arizona (Site #: 71144) city: Phoenix state: Arizona zip: 85054 country: United States name: Hugo Vargas, MD role: PRINCIPAL_INVESTIGATOR lat: 33.44838 lon: -112.07404 facility: University of California, San Francisco (Site #: 71108) city: San Francisco state: California zip: 94143 country: United States name: Joanna Kwan role: CONTACT phone: 415-476-2574 email: joanne.kwan@ucsf.edu name: Sandy Feng, MD role: PRINCIPAL_INVESTIGATOR lat: 37.77493 lon: -122.41942 facility: Northwestern University (Site #: 71110) city: Chicago state: Illinois zip: 60611 country: United States name: Dania Jahangir role: CONTACT email: dania.jahangir@northwestern.edu name: Justin Boike, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: Icahn School of Medicine at Mount Sinai (Site #: 71115) city: New York state: New York zip: 10029 country: United States name: Bharathi Ramesh role: CONTACT email: Bharathi.ramesh@mountsinai.org name: Thomas Schiano, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Duke University Medical Center (Site #: 71139) city: Durham state: North Carolina zip: 27710 country: United States name: Linda Perry role: CONTACT email: linda.perry@duke.edu name: Carl Berg, MD role: PRINCIPAL_INVESTIGATOR lat: 35.99403 lon: -78.89862 facility: University of Pennsylvania (Site #: 71111) city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Lexi Tumblety role: CONTACT phone: 267-441-1800 email: lexi.tumblety@pennmedicine.upenn.edu name: Abraham Shaked, MD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 facility: University of Pittsburgh Medical Center (Site #: 71162) city: Pittsburgh state: Pennsylvania zip: 15260 country: United States name: Lois Kipling role: CONTACT email: kniplingle@upmc.edu name: Scott Biggins, MD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 facility: Baylor Medical Center (Site #: 71153) city: Dallas state: Texas zip: 75246 country: United States name: Angela Roy role: CONTACT email: angela.roy@baylorhealth.edu name: Sumeet Asrani, MD role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 hasResults: False