Acute rejection and renal function are associated with long-term renal allograft survival. We evaluated these outcomes in patients receiving reduced TAC exposure combined with EVR or standard TAC exposure combined with MPA. Methods: In this single center prospective study, 288 low immunological risk kidney transplant recipients were randomized to receive (1) a single 3 mg/kg dose of antithymocyte globulin (rATG), reduced TAC exposure (<5 ng/ml), EVR (4-8 ng/mL) and prednisone (G1, n=85); (2) basiliximab (BAS), reduced TAC exposure (6 ng/ml for 3 months and <5 ng/mL 4-12 months), EVR (4-8 ng/mL) and prednisone (G2, n=102); (3) BAS, TAC (6-8 ng/ml), MPA (1440 mg/day) and prednisone (G3, N=101). Anti-HLA donor specific antibodies (DSA) and protocol biopsy were performed at 12 months. This analysis evaluated renal function at 12 months based on estimated glomerular filtration rate (eGFR) by MDRD, using the last observation carried forward method, and the binary composite of first treated biopsy confirmed acute rejection (tBCAR) and eGFR lower 50 mL/min. Results: Mean age was 45, 66% male and 52% Caucasian, with no differences among the groups. 69% were recipients of deceased donor kidney allografts, withno differences in mean kidney donor profile index (KDPI, 45%±22% vs. 52%±24% vs. 49%±24%) Final donor creatinine was higher in G1 (2.2±2.2 vs 1.6±1.1 vs 1.6±1.3 mg/dL, p=0.024). –

Donor age (odds ratio [OR]1.08, 95% confidence interval [ 95% CI], 1.05-1.11; P= 0.00), death due to cerebrovascular accident (OR 2.19, [ 95% CI] 1.26-3.82; P=0.00) and delayed graft function (OR 2.70,[ 95% CI] 1.52-4.84; P=0.00) were associated with eGFR lower 50 mL/min. The incidence of IF/TA in protocol biopsies (129/264) was 56% (57% vs. 58% and 54%, respectively, p=NS?). Conclusion: These data showed similar efficacy between rATG/EVR and the standard of care BAS/MPA, while preserving renal function at 12 months and recipients of extended criteria donors should be carefully evaluated once considering this treatment.

CITATION INFORMATION: Brigido A, Tedesco H, Felipe C, Cristelli M, Franco M, Medina-Pestana J. Efficacy and Renal Function in Kidney Transplant Recipients Receiving Tacrolimus (TAC)-Based Immunosuppressive Regimens in Combination with Everolimus (EVR) versus Mycophenolate (MPA). Am J Transplant. 2016;16 (suppl 3).

« Back to 2016 American Transplant Congress