Background: rATG dosed from 4.5 to 7.5mg/kg has been the standard of care in most transplant centers. Recent studies have demonstrated similar efficacy with doses <4.5mg/kg, which can reduce costs and adverse events. No study evaluated reduced rATG doses in patients receiving minimization maintenance regimen. The aim of this study is to evaluate the 1-year efficacy and safety of rATG 3mg/kg compared to 6mg/kg in low to moderate immunological risk patients receiving tacrolimus (TAC) low exposure plus everolimus (EVL) in a steroid-free protocol. Methods: Single-center, prospective, randomized, open-label clinical trial, including adult recipients of deceased donor kidney transplant with PRA≤50% and negative DSA. Patient enrollment began on 06/30/2015 and is intended to finish by Dec 2017 (100 in each group). Patients randomized to G1 received rATG 3mg/kg, starting during surgery. Patients on G2 received 3mg/kg, as in G1, plus two doses of 1.5mg/kg on post-operative days 2 and 4. The maintenance immunosuppressive regimen consisted of EVL C₀ 4-7ng/ml and TAC C₀ 4-7ng/ml. Results: The preliminary analysis of 85 patients (G1 n=42, G2 n=44), with a mean follow-up of 286 days, showed that most patients were men (63%), young (45±13yo) and recipients of standard criteria donor kidneys (98%). DGF incidence was similar (50 vs. 55%, p=0.829), but the duration was longer in G1 (25±30 vs 12±9;p=0.040). No significant difference was seen on biopsy-proven (10 vs 2%; p=0.265) or treated acute rejection (17 vs. 5%, p=0.085). There were no differences on CMV infection/disease incidence (12 vs. 18%, p=0.552), BKV viremia/nephropathy (0 vs. 2.3%, p=1.000) and on the incidence of infection requiring hospitalization (20 vs. 34%, p=0.150). Four patients lost their grafts, 3 (7.1%) on G1 and 1 (2.3%) on G2 (p=0.355) and 1 patient died on G1 (2.4 vs. 0%, p=0.488) Conclusion: These preliminary results show that induction with rATG at reduced doses in low to moderate risk patients receiving a steroid-free CNI minimization maintenance immunosuppressive regimen might be effective in the short term, without significant differences in safety outcomes.

CITATION INFORMATION: Sandes-Freitas T, Junqueira, Jr J, Girão C, Oliveira M, Esmeraldo R. Prospective Randomized Study to Evaluate the Efficacy and Safety of Rabbit Antithymocyte Globulin (rATG) 3mg/kg vs. 6mg/kg in Kidney Transplant Patients Under Steroid-Free and CNI Minimization Maintenance Immunosuppressive Regimen. Am J Transplant. 2017;17 (suppl 3).

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