*Purpose: To assess the effect of induction therapy on efficacy and safety outcomes of de novo renal transplant recipients (RTxR) receiving everolimus with reduced calcineurin inhibitor (EVR+rCNI) vs mycophenolate with standard CNI (MPA+sCNI) in the TRANSFORM (NCT01950819) study.

*Methods: In this 24-month (M), phase IV, multicenter, open-label study, adult RTxR stratified by induction type (basiliximab [Bax] or rabbit anti-thymocyte globulin [rATG]) were randomized (RND) to receive EVR+rCNI or MPA+sCNI with steroids. Efficacy assessments were incidence of binary composite of tBPAR or eGFR <50 mL/min/1.73 m², incidence of tBPAR, graft loss (GL), or death, and evolution of eGFR up to M24; safety assessments were incidence of adverse events (AE) and infections.

*Results: Of 2037 RND patients,1693 received Bax and 342 received rATG. Consistent with previous findings, the EVR+rCNI regimen was noninferior (P<0.001) to MPA+sCNI for the binary endpoint at M24 for both induction groups. At M24, incidences of tBPAR, GL, and death were comparable between EVR+rCNI and MPA+sCNI arms regardless of induction type (Table). Compared to Bax group, incidence of tBPAR was lower in both arms of rATG group. Mean eGFR was stable from Week 4 to M24 and comparable between arms at M24. Though the incidence of AE leading to study drug discontinuation was higher in EVR+rCNI arm, the incidence of AE leading to dose adjustment/interruption was higher in MPA+sCNI arm. Incidence of viral infections was lower in EVR+rCNI vs MPA+sCNI arm in both induction groups. Consistent with previous reports, incidence of CMV (Bax:8.4% vs 22.6%; rATG:10.1% vs 20.5%) and BKV (Bax:10.1% vs 14.1%; rATG:10.7% vs 20.5%) infections was lower in EVR+rCNI vs MPA+sCNI arm in both induction groups.

*Conclusions: Irrespective of the induction type, EVR+rCNI regimen offers comparable efficacy and safety and stable renal function to that of MPA+sCNI regimen up to M24 post-RTx.

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