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Long Term Outcomes in Kidney Transplant Recipients Receiving Everolimus (EVR) or Mycophenolate (MPS) in Combination with Tacrolimus (TAC)

K. Ficher, C. Rosso Felipe, Y. Cardoso Dreige, K. Linhares, A. Ferreira Brígido, S. Stopa, L. Viana, M. Cristelli, P. Gessolo Lins, W. Aguiar, H. Proença, R. Marco, M. Gerbase de Lima, H. Tedesco Silva Junior, J. Medina Pestana

Hospital do Rim, Nephrology Division, EPM - UNIFESP, São Paulo, Brazil

Meeting: 2019 American Transplant Congress

Abstract number: A235

Keywords: Graft survival, HLA antibodies, Immunosuppression, Renal function

Session Information

Session Name: Poster Session A: Kidney Immunosuppression: Novel Regimens and Drug Minimization

Session Type: Poster Session

Date: Saturday, June 1, 2019

Session Time: 5:30pm-7:30pm

 Presentation Time: 5:30pm-7:30pm

Location: Hall C & D

*Purpose: Detailed long-term data comparing the use of EVR or MPS in kidney transplant recipients receiving TAC is lacking.

*Methods: This is a 5-years extension analysis of data from a prospective trial including 288 patients who were randomized to receive a single 3mg/kg dose of rabbit antithymocyte globulin, TAC, EVR, and prednisone (r-ATG/EVR, n=85); basiliximab, TAC, EVR, and prednisone (BAS/EVR, n=102); or basiliximab, TAC, MPS, and prednisone (BAS/MPS, n=101). The primary end-point is the estimated glomerular filtration rate (eGFR) assessed with Modification of Diet in Renal Disease (MDRD) equation and the incidence of de novo donor specific antibodies (dnDSA). Secondary outcomes include first biopsy proven acute rejection, death, graft loss and loss to follow-up.

*Results: At 5 years mean tacrolimus concentrations was lower in EVR groups (5.2±2.2 vs. 5.7±2.4 vs. 7.2±2.5 ng/mL, p<0.001), but there were no differences in drug discontinuation rate (22.4% vs. 30.4% vs. 17.8%, p=0.103), respectively. Using a sensitive analysis with imputation of the last observed creatinine carried forward for patients who died or lost follow-up and zero for those who lost the graft before 60 months, only patients in the BAS/EVR group showed inferior renal function (45.2±29.3 vs. 41.5±24.3 vs. 51.6±32.2 ml/min/1.73m², p=0.042). Yet, renal function trajectories from 1 to 60 months were not different using a 2-way analysis of variance (p=0.142). There were also no differences in the urine protein to creatinine ratio (0.3±0.5 vs. 0.6±.7 vs. 0.3±0.6 g/g, p=0.066), in the incidence of dnDSA (6.5% vs. 11.7% vs 4.0%, p=0.185), cumulative incidence of the first biopsy proven acute rejection (15.3% vs. 27.5% vs. 20.8%, p=0.128), graft loss (12.9% vs. 9.8% vs. 14.9%, p=0.548), death (7.1% vs. 5.9% vs. 7.9%, p=0.848) or loss to follow up (1.2% vs. 7.8% vs. 1.0%, p=0.057).

*Results: At 5 years mean tacrolimus concentrations was lower in EVR groups (5.2±2.2 vs. 5.7±2.4 vs. 7.2±2.5 ng/mL, p<0.001), but there were no differences in drug discontinuation rate (22.4% vs. 30.4% vs. 17.8%, p=0.103), respectively. Using a sensitive analysis with imputation of the last observed creatinine carried forward for patients who died or lost follow-up and zero for those who lost the graft before 60 months, only patients in the BAS/EVR group showed inferior renal function (45.2±29.3 vs. 41.5±24.3 vs. 51.6±32.2 ml/min/1.73m², p=0.042). Yet, renal function trajectories from 1 to 60 months were not different using a 2-way analysis of variance (p=0.142). There were also no differences in the urine protein to creatinine ratio (0.3±0.5 vs. 0.6±.7 vs. 0.3±0.6 g/g, p=0.066), in the incidence of dnDSA (6.5% vs. 11.7% vs 4.0%, p=0.185), cumulative incidence of the first biopsy proven acute rejection (15.3% vs. 27.5% vs. 20.8%, p=0.128), graft loss (12.9% vs. 9.8% vs. 14.9%, p=0.548), death (7.1% vs. 5.9% vs. 7.9%, p=0.848) or loss to follow up (1.2% vs. 7.8% vs. 1.0%, p=0.057).

*Conclusions: Among low/moderate immunologic risk kidney transplant recipients, the induction with a single dose of rabbit antithymocyte globulin and the use of everolimus and reduced dose of tacrolimus as maintenance therapy is safe and comparable with the standard of care at long term.

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To cite this abstract in AMA style:

Ficher K, Felipe CRosso, Dreige YCardoso, Linhares K, Brígido AFerreira, Stopa S, Viana L, Cristelli M, Lins PGessolo, Aguiar W, Proença H, Marco R, Lima MGerbasede, Junior HTedescoSilva, Pestana JMedina. Long Term Outcomes in Kidney Transplant Recipients Receiving Everolimus (EVR) or Mycophenolate (MPS) in Combination with Tacrolimus (TAC) [abstract]. Am J Transplant. 2019; 19 (suppl 3). https://atcmeetingabstracts.com/abstract/long-term-outcomes-in-kidney-transplant-recipients-receiving-everolimus-evr-or-mycophenolate-mps-in-combination-with-tacrolimus-tac/. Accessed May 11, 2025.

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