Ten-years data of the first European clinical experience with once-daily tacrolimus extended release formulation in renal transplant recipients

Background: Clinical data about long-term use of tacrolimus QD are lacking. Methods: Ten-years data were collected from 37 renal transplant recipients participating in a Tacrolimus BID (Prograf®) to QD (Advagraf®) conversion study. They were converted at a median of 4.1 years post-transplant (range 1.5-11.4) with a stable renal function (serum creatinine < 264 umol/L) on tacrolimus based immunosuppression (monotherapy 29, dual therapy 8). Thirty were first transplants and original renal disease was in 16 immunologic, 14 non-immunologic, and 7 unknown. Eleven received their kidney from a living donor. Results: There were no acute rejections. Thirty-four recipients were on tacrolimus QD up to end of follow-up. Three patients were censored at 2, 3, and 4 years post-conversion. Actuarial 5- and 10-year patient survival rates were 92% and 85%, respectively. Five patients died with a functioning graft 1.2 - 9.2 years post-conversion. Actuarial 5- and 10-year death-censored graft survival rates were 100% and 83%, respectively. The 5 graft losses occurred at 8.2 - 9.0 years post-conversion (3 due to recurrence IgA nephropathy, chronic rejection, and renal failure after cardiac surgery). Serum creatinine was 128 umol/L (range 64-180) at conversion and 141 umol/L (range 66-304) at 10 years. All patients with a non-immunologic cause of renal failure had a stable creatinine, while the 8 patients with an increase in serum creatinine >20% had an immunological or unknown cause of renal failure. Conclusion: Patients on tacrolimus QD have excellent 10-year renal function, patient - and graft survival.