*Purpose: The BEST Trial (Belatacept-based Early Steroid Withdrawal Trial) is a prospective, randomized, multi-center trial designed to compare two belatacept (BELA)-based calcineurin inhibitor-free (CNI), early corticosteroid withdrawal (ESW) regimens with a standard of care (SOC) tacrolimus (TAC)-based ESW regimen. This report presents final two-year results of this trial.

*Methods: This study was conducted under an FDA IND and IRB approval at each of eight sites. Adult kidney transplant (KTx) recipients of living and deceased donor allograft were eligible for enrollment. All patients received mycophenolate therapy and a five-day steroid taper. 316 patients were randomized to three treatment groups: alemtuzumab + BELA (Group A), rATG + BELA (Group B), and rATG + TAC (Group C). Primary endpoint was a composite of: patient death or graft loss or estimated GFR < 45ml/min/m2 and the components are presented as 2-year actuarial rates in Table 1.

*Results: Enrollment was completed on 12/15/16. Intent to treat (ITT) analyses on patients with 2 year follow-up as of 11/1/18 are presented in Table 2.

*Conclusions: The primary endpoint was similar among all groups, however, there were differences in secondary endpoints. Regarding quality of renal function, the proportion of patients with eGFR <45ml/min was significantly higher in the TAC group. However, rejection rates were significantly higher in the BELA groups, and approximated 20-25% over 2-years. Tolerability (GI toxicity, neurotoxicity, and metabolic adverse events) was significantly improved in BELA treated patients compared to TAC. This CNI- and steroid-free IS protocol is a promising step forward in minimizing toxicities and improving renal allograft function. Longer-term observations will need to be continued.

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