Conditions: Liver Transplantation
Keywords: Liver transplantation, everolimus, CNI
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 276
Healthy volunteers: no

Brief summary:
The study is designed to show that everolimus initiation together with reduction and thereafter discontinuation of calcineurin inhibitor (CNI) will improve significantly renal function in de novo liver transplant recipients as compared to continuation of CNI-based treatment.

Detailed description:

Arms:
arm 1: Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice arm 2: Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice

Interventions: intervention 1: everolimus intervention 2: basiliximab intervention 3: CNI
Intervention descriptions: intervention 1: Start dose of everolimus was 1.5 mg in the morning followed by 1.5 mg in the evening. After one week, the dose was adjusted to achieve trough levels between 5-12 ng/mL. Once trough levels were above 5ng/mL, the CNI dose was reduced to 70%. At week 8 post-baseline (latest at week 16 post baseline), CNI was completely discontinued. For patients receiving Ciclosporin A (CiA) as CNI, the everolimus dosage was adjusted to achieve a trough level of 8-12 ng/mL, prior to discontinuation of CiA. After discontinuation of CNI, everolimus was maintained at a trough level of 5-12 ng/mL. intervention 2: All patients who met the eligibility criteria were treated with 2 doses of basiliximab on Day 0 (transplantation) and Day 4. intervention 3: Patients who met the screening eligibility received CNI-based immunosuppressive therapy for 1 month. Then at week 4 (or week 8 at maximum), patients randomized to the CNI arm continued on CNI-based immunosuppressive therapy.

Protocol document: