Long‐term prolonged‐release tacrolimus outcomes in living donor kidney transplantation: The Japan Academic Consortium of Kidney Transplantation study‐II

Objectives To evaluate the 10‐year efficacy and safety of a prolonged‐release tacrolimus‐based combination immunosuppressive regimen on longer‐term outcomes in living donor kidney transplantation. Methods Data from Japanese living donor kidney transplant recipients ( n = 410) maintained on continuous prolonged‐release tacrolimus‐based immunosuppression from 2009–2013 were analyzed with a median follow‐up of 9.9 years. Results A prolonged‐release, tacrolimus‐based combination regimen provided death‐censored graft failure and all‐cause death rates at 10 years of 7.0% and 6.8%, respectively. In multivariable analyses, acute and chronic rejection and ‘throughout’ (new‐onset plus preexisting) diabetes mellitus were risk factors for death‐censored graft failure. Recipient age ≥ 65 years, throughout diabetes mellitus and malignancy were common risk factors for all‐cause death. Throughout diabetes mellitus was the most common risk factor for both death‐censored graft failure and all‐cause death. Additional analyses showed 10‐year cumulative rates of death‐censored graft failure were 14.0% and 5.4% for recipients with or without preexisting diabetes mellitus, respectively (log‐rank test: p = 0.009). All‐cause death rates were 12.7% and 5.4% in the preexisting and non‐diabetes mellitus groups, respectively (log‐rank test: p = 0.023). Conclusions In this real‐world, retrospective, living donor kidney transplantation study, a prolonged‐release tacrolimus‐based immunosuppressive combination regimen provided 10‐year death‐censored graft failure rates of 14.0% and 5.4% in diabetes mellitus and non‐diabetes mellitus patients, respectively; Similarly, 10‐year all‐cause death rates were 12.7% and 5.4% in diabetes mellitus and non‐diabetes mellitus patients, respectively. To our knowledge, the data in this study are the first to provide 10‐year transplant outcomes in living donor kidney transplant recipients under prolonged‐release tacrolimus‐based regimen.