Everolimus Plus Early Tacrolimus Minimization: a Phase III, Randomized, Open-label, Multicentre Trial in Renal Transplantation.
Langer RM, Hene R, et al.Transplant International, 25(5): 592-602, 2012.
Aims
To evaluate the efficacy and safety of everolimus combined with early tacrolimus minimization in renal transplantation recipients.
Interventions
Tacrolimus exposure reduced to trough target levels of 1.5–3 ng/ml versus continuation of tacrolimus at trough target levels of 4–7 ng/ml at 4-month post-transplantation. All patients received tacrolimus at trough target levels of 4–7 ng/ml and everolimus in combination with basiliximab induction and corticosteroids during the first 3 months post-transplantation.
Participants
228 renal transplant recipients.
Outcomes
The primary outcome was renal function assessed by estimated glomerular filtration rate (GFR) at 12 months. The secondary outcome included the incidence of biopsy proven acute rejection, graft loss, death or lost to follow-up, serum creatinine and creatinine clearance. Safety endpoints included the incidence of adverse events and serious adverse events and the incidence of new onset diabetes mellitus over 12 months.
Follow-up
12 months post-transplantation
CET Conclusions
In this open label randomised study, all patients received tacrolimus, everolimus and steroids. Reduction of tacrolimus at 3 months in one arm was compared with continuation of the same tacrolimus dosage (as defined by trough levels). At one year, there was no difference in estimated GFR nor was there any difference in the incidence of biopsy proven acute rejection from months 4 to 12 or in serious adverse events.
Data analysis
Available case analysis
Trial registration
NCT00369161 (ClinicalTrials.gov)