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An open-label, randomized trial indicates that everolimus with tacrolimus or cyclosporine is comparable to standard immunosuppression in de novo kidney transplant patients

Kidney International Mar 07, 2019

Sommerer C, et al. - Via performing a randomized trial (ATHENA study) in de novo kidney transplant patients, researchers compared everolimus vs mycophenolic acid (MPA) with similar tacrolimus exposure in both groups, or everolimus with concomitant tacrolimus or cyclosporine (CsA), in an unselected population. They performed randomization of de novo kidney transplant recipients to everolimus with tacrolimus (EVR/TAC), everolimus with CsA (EVR/CsA) or MPA with tacrolimus (MPA/TAC), with similar tacrolimus exposure in both groups. The per-protocol population of 338 patients did not display non-inferiority of the primary endpoint (estimated glomerular filtration rate (eGFR) at month 12) for EVR/TAC or EVR/CsA vs MPA/TAC. The groups were comparable regarding eGFR outcomes in 123 patients with TAC levels within the protocol-specified range. With EVR/TAC or EVR/CsA vs MPA/TAC, they observed a similar mean increase in eGFR during months 1 to12 post-transplant, analyzed post hoc. For EVR/TAC, no significant treatment failure (biopsy proven acute rejection, graft loss or death) was observed but treatment failure was significant for EVR/CsA vs MPA/TAC. In this study, most biopsy proven acute rejection events were graded as mild (BANFF IA). The groups showed no differences in terms of proteinuria. With MPA/TAC, significantly more frequent cytomegalovirus and BK virus infection were reported.
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