To evaluate the clinical utility of a miRNA-based signature for detecting alloimmune activation and early liver injury, when used in conjunction with conventional biochemical monitoring, to guide calcineurin (CNI) immunosuppression minimization in stable liver transplant recipients transplanted for non-immune liver diseases at least one year after transplantation.
This is a multicenter, prospective, open-label, randomized controlled trial in stable liver transplant recipients receiving a CNI-based immunosuppression regimen. Participants will undergo closely monitored immunosuppression minimization with a target reduction of the CNI dose to 50% of the baseline maintenance dose.
Participants will be randomized in a 1:1 ratio to one of two immunosuppression minimization strategies: (1) guidance by a miRNA-based biomarker in conjunction with conventional biochemical monitoring, or (2) guidance by conventional biochemical monitoring alone.
