Everolimus bAsed caLcineurin inhibiTor frEe immunosuppRession oNe year AfTer lIver transplantatiON (ALTERNATION) – a randomized, prospective, multicenter, open-label, controlled phase III trial

Patients after the first year following liver transplantation

Change in estimated glomerular filtration rate (eGFR (ml/min)) from baseline to 14 months after randomization – eGFR will be calculated using the CKD-EPI Creatinine equation according to the national kidney foundation, 2021.(1)

Biopsy-proven acute liver graft rejection or liver graft loss (whichever occurs first) until month 14. Biopsy proven acute rejection (BPAR) (yes/no) is defined as liver enzyme elevation above 2xULN and histological criteria according to the most recent BANFF consensus.(2), Change in estimated glomerular filtration rate (eGFR (ml/min)) from baseline to end of follow-up (38 months), Biopsy- proven acute liver graft rejection or liver graft loss (whichever occurs first) until month 38, Progression of chronic kidney disease to stage 4, 5 or requirement for renal replacement therapy (yes/no), Incidence of liver-related mortality (yes/no), Progression of subclinical graft injury (fibrosis) at rebiopsy at month 14 and end of follow-up, where progression in the svLBx is defined as reaching histological exclusion criteria from baseline biopsy (≥ 2 points), Progression of subclinical inflammation at rebiopsy at month 14 (yes/no) and end of follow-up (yes/no), where inflammation in the svLBx is defined as reaching exclusion criteria from baseline biopsy (≥ 2 points in any subscore), Quality of life: change from baseline to months 14 and end of follow-up (measured with PROMIS and SF-36), De novo development of donor specific HLA antibodies (yes/no), Increase in liver stiffness above 8,4 kPa (yes/no), Incidence of malignancy (yes/no), Occurrence of infections requiring medical intervention or hospitalization (yes/no), New onset of comorbidities including hypertension (yes/no), dyslipoproteinemia (yes/no) and diabetes mellitus (yes/no)

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