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 low exposure of tacrolimus (TAC) 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. The enrollment initiated on 06/30/2015 and is planned to finish in June 2017 (expected sample: 100 in each group). Patients randomized to G1 received rATG 3mg/kg (1.5mg/kg x2 doses) and G2 received 6mg/kg (1.5mg/kg x4 doses). The maintenance immunosuppressive therapy consisted of EVL C₀ 4-7ng/ml and TAC C₀ 4-7ng/ml. Results: We report here a preliminary analysis of 35 patients (G1 n=17, G2 n=18), with a mean follow-up of 102.3 days. Patients were predominantly men (63%), young (43±11y) and recipients of standard criteria donors (88%). The mean cold ischemia time was 21±7 hours and 45% of the kidneys were machine perfused. A lower lymphocyte count was observed in G1 at D7 (382±170 vs. 192±113/mm³, p=0.001), D15 (730±269. vs. 433±213/mm³, p=0.002) and at D30 (1048±294 vs. 601±385/mm³, p=0.001), but not at D60 (1186±373 vs. 1011±558/mm³, p=0.381). There were no differences regarding the incidence of DGF (43 vs. 53%, p=0.722), acute rejection (7 vs. 6%, p=1.00), and CMV infection/disease (14.3 vs. 17.6%, p=1.00). Despite not statistically significant, patients in G2 presented a higher length of hospital stay after transplantation (13±7 vs. 18±10 days, p=0.178) and a higher incidence of infection within the first month (21 vs. 41%, p=0.280). Conclusion: These preliminary results show that induction with rATG at reduced doses in low to moderate risk patients receiving a minimization maintenance immunosuppressive regimen seems to be effective in the short term, and can provide a better safety profile.

CITATION INFORMATION: Sandes-Freitas T, Junqueira Junior J, Oliveira M, Girão C, Esmeraldo R. A Prospective Randomized Study to Evaluate the Efficacy and Safety of Rabbit Antithymocyte Globulin (rATG) 3mg/Kg vs. 6mg/Kg in Kidney Transplant Patients Under Minimization Maintenance Immunosuppressive Regimen. Am J Transplant. 2016;16 (suppl 3).

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