A Randomized, Controlled Study to Assess the Conversion from Calcineurin-Inhibitors to Everolimus after Liver Transplantation-PROTECT.
Fischer L, Klempnauer J, et al.American Journal of Transplantation, 12(7):1855-1865, 2012.
Aims
To assess the effects of everolimus on renal function after conversion from calcineurin inhibitors (CNIs) compared to continuous CNI treatment.
Interventions
Continued CNIs versus conversion to everolimus at 4 weeks post-liver transplantation. All patients received basiliximab induction, CNI with/without corticosteroids before randomization.
Participants
203 de novo liver transplantation recipients.
Outcomes
Primary efficacy endpoint was renal function measured as glomerular filtration rate (GFR) over 1-year following transplantation. The other efficacy outcomes included biopsy-proven acute rejection, graft loss, death or loss to follow-up from any reason. Safety assessment included the incidence of adverse events, serious adverse events, arterial hypertension, hyperlipidemia, anemia, leukopenia and infections.
Follow-up
12 months post-transplantation
CET Conclusions
Patients with a liver transplant on CNI therapy were converted 4-8 weeks after transplantation to everolimus or remained on standard CNI therapy. The primary end point was estimated GFR at 12 months using the Cockroft-Gault formula and this was no different at 1 year between the two arms. Nor was there any difference in patient survival, graft survival, acute rejection or morbidity. A post hoc analysis of estimated GFR using the MDRD formula did show a modest superiority of renal function in the group converted to everolimus.
Data analysis
Available case analysis
Trial registration
NCT00378014 (ClinicalTrials.gov)