Randomized trial of everolimus-facilitated calcineurin inhibitor minimization over 24 Months in renal transplantation.
Cibrik D, Silva HT Jr, et al.Transplantation. 2013; 95(7):933-42
Aims
To investigate the long term outcomes of reduced cyclosporine A (CsA) exposure on graft and patient survival and rates of acute rejection in kidney transplant patients.
Interventions
Patients were randomized to receive reduced exposure CsA plus everolimus 0.75mg b.i.d (targeting blood concentrations of 3-8 ng/mL) or everolimus 1.5mg b.i.d (targeting blood concentrations of 6-12ng/mL), or mycophenolic acid (MPA) 1.44g per day with standard exposure CsA. All patients received 20mg basiliximab. Corticosteroids were administered according to local center practice.
Participants
833 adult renal transplant recipients, with low to moderate immunologic risk
Outcomes
The primary efficacy outcomes included: treated biopsy proven acute rejection, graft loss, death or loss to follow up. Safety outcomes included renal function, incidence of premature study discontinuation, study treatment discontinuation, adverse events and clinical laboratory measurements (biochemistry,hematology, urinalysis, and endocrinology).
Follow-up
2 years.
CET Conclusions
In this large multicentre randomised trial of low risk recipients of a renal transplant no difference was found in the incidence of acute rejection, graft survival or patient death between the three arms of the trial. These were low risk recipients and all patients were induced with basiliximab with or without steroids, however it should be noted that the higher incidence of adverse events led to significant discontinuation in the everolimus groups compared with the MPA group.
Data analysis
Strict intention-to-treat analysis
Trial registration
ClinicalTrials.gov – NCT00251004