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Prospective randomized study comparing everolimus and mycophenolate sodium in de novo kidney transplant recipients from expanded criteria deceased donor

Alexandra Nicolau Ferreira, Claudia Rosso Felipe, Marina Cristelli, Laila Viana, Juliana Mansur, Mayara de Paula, Daniel Wagner, Renato de Marco, Maria Gerbase de Lima, Henrique Proença, Wilson Aguiar, Jose Medina- Pestana, Helio Tedesco-Silva Junior
Transplant International: Official Journal of the European Society for Organ Transplantation 2019 July 6

BACKGROUND: The optimal immunosuppressive regimen for recipients of expanded criteria donors (ECD) kidneys has not been identified.

METHODS: In this single-center study, 171 recipients of ECD kidney transplants were randomized to receive antithymocyte globulin induction, delayed introduction of reduced dose tacrolimus, prednisone and everolimus (r-ATG/EVR, n=88) or mycophenolate (r-ATG/MPS, n=83). No cytomegalovirus (CMV) pharmacological prophylaxis was used. The primary end-point was the incidence of CMV infection/disease at 12 months. Secondary endpoints included treatment failure (first biopsy-proven acute rejection [BPAR], graft loss or death) and safety.

RESULTS: Patients treated with EVR showed a 89% risk reduction (13.6 vs. 71.6%; HR 0.11, 95%CI 0.06 - 0.220, p<0.001) in the incidence of first CMV infection/disease. Incidences of BPAR (16% vs. 5%, p=0.021), graft loss (11% vs. 1%, p=0.008), death (10% vs. 1%, p=0.013), and treatment discontinuation (40% vs. 28%, p=0.12) were higher in the r-ATG/EVR, leading to premature study termination. Mean glomerular filtration rate was lower in r-ATG/EVR (31.8±18.8 vs. 42.6±14.9, p<0.001).

CONCLUSIONS: In recipients of ECD kidney transplants receiving no CMV pharmacological prophylaxis, the use of everolimus was associated with higher treatment failure compared to mycophenolate despite the significant reduction in the incidence of CMV infection/disease. (ClinicalTrials. gov.NCT01895049). This article is protected by copyright. All rights reserved.


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