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.
Subject and/or legal guardian must be able to understand and provide informed consent
Adult (age greater than or equal to 18 years of age at time of informed consent) recipient of first liver transplant alone (de novo)
Estimated glomerular filtration rate >=30 ml/min/1.73m² at enrollment using the CKD-EPI 2021 equation
Treatment with tacrolimus therapy, with or without mycophenolic acid derivatives and/or corticosteroids
Inability or unwillingness of a participant to give written informed consent or comply with study protocol
Active unresolved systemic viral, bacterial, fungal, or parasitic infection requiring oral or intravenous anti-infective therapy
History of autoimmune liver disease including autoimmune hepatitis, primary sclerosing cholangitis, and/or primary biliary cirrhosis, or other contraindications to drug withdrawal
History of non-hepatic autoimmune disease requiring current or future systemic immunosuppressive therapy other than per study protocol