Exclusion criteria
thrombosis, ®, treatedHepatocellular carcinoma, occlusion, amenorrhea, Multi-organ transplantationAny, extra-hepatic malignancy, hypersensitivity, tubal occlusion
THROMBOSIS, HYPERSENSITIVITY

Multi-organ transplantationAny previous organ allograft transplantationBiopsy-proven acute rejection that is ongoing at the time of randomisationOccurrence of post-transplant thrombosis, occlusion or stent placement in any major hepatic arteries, hepatic veins, portal vein or inferior vena cavaHistory of extra-hepatic malignancy that could not be curatively treatedHepatocellular carcinoma with extra-hepatic spread or macrovascular invasionUncontrolled systemic infectionRequirement of life support measures such as ventilation or vasopressor agents (> 20 μg/kg BW/h) at the time of randomisationKnown contraindication or hypersensitivity to tacrolimus, and/or to any of the excipients listed in Sect. 6.1 of the Summary of Product Characteristics (SmPC) of both Envarsus® and Advagraf™, and/or to any other macrolidesOngoing, planned or foreseeable use of cyclosporine or any tacrolimus preparation other than Envarsus® or Advagraf.™ (except for immediate-release formulations administered before randomisation)Any prolonged-release tacrolimus treatment prior to randomisationPregnant or nursing (lactating) female, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory testFemale of child-bearing potential, defined as physiologically capable of becoming pregnant, unless using a reliable method of contraceptionParticipation in another interventional clinical trial during the time period from randomisation to study end, if the trial is testing an IMP (AMG study) or if the intervention and/or follow-up requirements of the trial impede or interfere with either the objectives of EnGraft or the treatment/follow-up requirements of EnGraftAny condition or factor which, in the judgement of the investigator, would place the subject at undue risk, invalidate communication with the investigator or study team, or hamper compliance with the trial protocol or follow-up scheduleInability to freely give informed consent (e.g. individuals under legal guardianship)All women of childbearing potential will undergo a serum pregnancy test prior to transplantation as per site routine. Postmenopausal women (physiologic menopause defined as 12 consecutive months of amenorrhea) or women who are permanently sterilised (e.g. tubal occlusion, hysterectomy or bilateral salpingectomy) may be enrolled in the study without serum pregnancy testing.