Comparative Study of 2 Extended-Release Tacrolimus Formulations in Kidney Transplantation

Background. During the 1900s, tacrolimus became the mainstay immunosuppressive agent to prevent rejection after kidney transplant. Subsequently, an extended-release tacrolimus (ER-Tac) formulation was developed to improve adherence, and its generic version has been marketed over the last years. This study examines the differences in efficacy and safety between the generic ER-Tac (Conferoport) and the reference brand-name drug (Advagraf). Methods. Prospective, randomized and parallel single-center study (May 2020 to June 2021) with 52 kidney transplant recipients who were randomly assigned to 1 of the following groups: study group (Conferoport, n = 31) and control group (Advagraf, n = 21). The variables of interest were collected and analyzed to compare tacrolimus efficacy and safety between them. Demo-graphic characteristics of the patients and clinical donor data were homogeneous in both groups (P > .05).Results. No statistically significant differences were found among treatments regarding dos-age used, levels, creatinine, and proteinuria (P > .05), with these variables presenting a down-ward trend during follow-up and, consequently, the improvement of graft function. Analyses also revealed the absence of differences concerning the incidence of acute rejection and intrapa-tient variability (coefficient of variation) throughout the first year of evolution between both for-mulations (P > .05). A total of 5 graft losses occurred, 2 resulting from patient death.Conclusions. In our experience, we found no significant differences between the measured parameters in relation to the efficacy and safety profile of both drugs, with generic ER-Tac being an alternative comparable with the reference brand-name ER-Tac.