Conditions: Liver Transplantation
Keywords: Liver transplantation, everolimus, calcineurin inhibitor, renal function
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 145

Brief summary:
The purpose of the study is to assess the effect of everolimus initiation together with reduction or discontinuation of calcineurin inhibitor (CNI) on renal function in maintenance liver transplant recipients with CNI-related renal impairment, while maintaining efficacy.

Detailed description:

Arms:
arm 1: Reduced CNI dose + everolimus (1.5 mg twice daily (b.i.d)) ± steroids arm 2: Standard CNI dose ± MPA/AZA ± steroids

Interventions: intervention 1: Everolimus intervention 2: Calcineurin inhibitors (CNI) intervention 3: Mycophenolate acid (MPA)/ Azathioprine (AZA) intervention 4: Steroids
Intervention descriptions: intervention 1: 1.5 mg bid adjusted in order to achieve a trough level between 3 and 8 ng/mL while in combination with CNI and between 6 and 12 ng/mL after CNI discontinuation intervention 2: None intervention 3: None intervention 4: None

Protocol document: