Background: African American (AA) de novo renal transplant recipients (RTxR) are at high risk of graft loss and rejection. This sub-analysis reports data in AA de novo RTxR from a 12M, multicenter randomized, open-label non-inferiority study that evaluated the efficacy and safety of everolimus (EVR)+low-dose tacrolimus (LTac) vs mycophenolate mofetil (MMF)+standard-dose Tac (STac). Methods: In this de novo RTxR (n=613) received EVR (starting at 0.75 mg bid)+LTac or MMF (2 g/day)+STac. All patients (pts) received induction therapy based on immunological risk factors (basiliximab if PRA<20%; or Rabbit anti-thymocyte globulin if PRA ≥20% or high risk) and steroids per local practice. Composite efficacy failure rate at 12M included BPAR, graft loss, death, or lost to follow-up. Renal function (eGFR [MDRD]) was also measured at 12M. Results: Of 613 pts, 144 were AA (EVR+LTac=70, 22.7%; MMF+STac=74, 24.3%). The EVR+LTac (vs MMF+STac) group had fewer living donor recipients (18.6% vs 24.3%) and PRA ≥20% (22.9% vs 35.1%). Moreover, recipients of organs from ECD (11.4% vs 6.8%) and pts with HLA mismatches ≥3 (92.9% vs 85.1%) were more frequent in EVR+LTac vs MMF+STac. Other donor and recipient characteristics were comparable between treatment groups. Composite efficacy failure rates were comparable between treatment groups (Table). Mean eGFR at 12M was also similar (EVR+LTac, 60.8 vs MMF+STac, 60 mL/min/1.73m2). Incidence of any serious adverse event 12M post-transplant was comparable with EVR+LTac vs MMF+STac (52.9%, n=37 vs 60.8%, n=45). The infection rates were lower with EVR+LTac (58.6%) vs MMF+STac (71.6%).Table: No Caption available.Conclusions: Despite the higher risk profile of de novo AA renal transplant recipients in EVR+LTac arm, the efficacy results were similar to MMF+STac. EVR-facilitated Tac minimization also preserved renal function compared to standard therapy and provided lower infection rates. DISCLOSURES:Peddi, V.: Grant/Research Support, Novartis, Astellas. Shaffer, D.: Grant/Research Support, Novartis. Shihab, F.: Other, Novartis, Consultant and Speaker, Astellas, Consultant. McCague, K.: Employee, Novartis Pharmacutical Corporation. Patel, D.: Employee, Novartis Pharmacutical corporation. Mulgaonkar, S.: Grant/Research Support, Novartis, Other, Novartis, Advisor.