*Purpose: To assess the efficacy and safety outcomes in de novo renal transplant (RTx) recipients receiving everolimus with reduced-exposure calcineurin inhibitor (EVR+rCNI) versus mycophenolate with standard-exposure CNI (MPA+sCNI) by donor type (living donor [LD] versus deceased donor [DD]) in TRANSFORM (NCT01950819) study.

*Methods: In this 24-month (M), Phase 4, multicenter, open-label study, 2037 adult patients were randomized to receive EVR+rCNI or MPA+sCNI with steroids and basiliximab or rabbit antithymocyte globulin as induction therapy. Efficacy assessments were incidence of binary composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) <50 mL/min/1.73 m², incidence tBPAR, graft loss, or death, and evolution of eGFR up to M24; safety assessments were incidence of adverse events (AEs) and infections.

*Results: In all, 1018 and 1011 patients received allografts from LD and DD, respectively. Demographics and baseline characteristics were similar between the treatment arms of both donor groups. Incidence of binary composite endpoint was comparable between EVR+rCNI and MPA+sCNI regimens in both donor groups (LD: P = 0.242; DD: P = 0.145) at M24. Regardless of the donor types, incidence of tBPAR, graft loss, and death were comparable between the treatment arms. Compared with patients in the DD group, mean eGFR was numerically higher in both treatment arms of the LD group (Table). Overall incidence of infections was numerically lower in the EVR+rCNI arm versus MPA+sCNI arm of both donor groups.

*Conclusions: Irrespective of donor type, EVR+rCNI regimen offers comparable efficacy and safety and stable renal function as MPA+sCNI regimen up to M24 post-transplant.

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