Everolimus Monotherapy as Immunosuppression After Liver Transplant
Status:
Recruiting
Trial end date:
2028-12-01
Target enrollment:
Participant gender:
Summary
Tacrolimus is the standard immunosuppressive drug used to prevent organ rejection post liver
transplant. One side effect of Tacrolimus is nephrotoxicity. Everolimus does not have the
nephrotoxicity side effects of Tacrolimus.
Replacement of Tacrolimus by Everolimus may have a reduced incidence of renal dysfunction in
liver transplant patients who have near normal kidney function prior to liver
transplantation. Other investigators have already shown a benefit in terms of renal function
with introduction of Everolimus with reduced-exposure tacrolimus at 1 month after liver
transplantation, this benefit has been shown was maintained to 3 years in patients who
continued Everolimus therapy with comparable efficacy and no late safety concerns.
Investigators in this trial are proposing to advance this approach further by completely
eliminating Tacrolimus from patients' immunosuppression protocol. The rationale for this
approach is based on a unique induction immunosuppression protocol.
Liver transplant patients receive potent induction immunosuppression in the form of rabbit
anti thymocyte globulin.
Investigators believe that in conjunction with this induction regimen, patients can be
maintained on Everolimus monotherapy without the risk of rejection. By completely eliminating
Tacrolimus, investigators believe that there may be further benefit in terms of renal
function. Additionally, Everolimus is known to induce tolerance in transplant recipients.
Tolerant patients do not require immunosuppression to accept transplant organs.
The long-term efficacy and safety of Everolimus monotherapy as the maintenance
immunosuppression in patients receiving rATG induction is unknown.
Primary Aim: Assess the effect of Everolimus monotherapy versus Tacrolimus monotherapy on
long term renal function measured by Glomerular Filtration Rate (GFR).