Background; Previously, we reported a comparison of the safety and pharmacokinetics between a prolonged-release formulation of Tacrolimus (Tac-QD) and twice-daily tacrolimus (Tac-BD) in the early phase after kidney transplantation. In this study, we report longer-term results in 5 years after the aforementioned prospective study. Materials and methods; Between November 2009 and January 2011, 130 consecutive adult patients were randomized to receive either low-dose Tac-QD or Tac-BD. The transplant operation was cancelled due to other reasons after enrollment in this study in 9 cases. During the observation period, the treatment was switched from Tac-BD to Tac-QD in 5 cases, and from Tac-QD to Tac-BD in 2 cases respectively. In 2 cases, tacrolimus was switched to cyclosporine. One patient died due to cancer and 5 cases lost their grafts. In cases that meet criteria of this study, we examined the patient and graft survival rates, the incidence rates of graft rejection, the serum tacrolimus trough level, and the total oral dose of tacrolimus. Results; The patient survival rates are 100% and 97.4% in the QD and BD groups. The graft survival rate are 100% and 89.7% in the QD and BD groups. The current tacrolimus dose is 0.06±0.04 mg/kg/day in the QD group and 0.08±0.07 mg/kg/day in the BD group (P=0.455). The mean tacrolimus trough level is 4.6±1.6 ng/ml in the QD group and 3.7±0.4 ng/ml in the BD group (P=0.219). There is no statistically significant difference in the graft function between the QD and BD groups (serum creatinine level; 1.18±0.27 mg/dl in the QD group vs. 1.20±0.26 mg/dl in the BD group; P=0.899). The incidence rate of acute/chronic T cell-mediated rejection until 5 years after Tx was 7.9% in the QD group and 7.7% in the BD group (P=0.974). The incidence rate of acute/chronic antibody-mediated rejection until 5 years after Tx was 21.1% in the QD group and 20.6% in the BD group (P=0.836). There has been no significant difference in the graft rejection rate, CNI toxicity, incidence of BK nephropathy and recurrence of IgA nephropathy between the two groups. Conclusion; The clinical efficacy and safety profile of Tac-QD and Tac-BD were proved even in 5 years after kidney transplantation, which was almost similar to previous report.

CITATION INFORMATION: Tsuchiya T, Ishida H, Nozaki T, Shirakawa H, Shimizu T, Omoto K, Okumi M, Tanabe K. Comparison of Once-Daily and Twice-Daily Low-Dose Tacrolimus in Living Related Kidney Transplantation – Prospective Trial of Once-Daily vs. Twice-Daily Tac – 5 Years Second Report. Am J Transplant. 2016;16 (suppl 3).

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