Safety and efficacy of conversion from twice-daily tacrolimus to once-daily tacrolimus one month after transplantation: randomized controlled trial in adult renal transplantation.

Abstract

PURPOSE: The purpose of this study was to compare once-daily tacrolimus with

twice-daily tacrolimus in terms of safety, efficacy, and patient satisfaction.

MATERIALS AND METHODS: This prospective, randomized, open-label, multicenter

study was conducted at three institutes. Patients in the investigational group

were converted from tacrolimus twice daily to the same dose of extended-release

tacrolimus once daily at 1 month post-transplantation, while patients in the

control group were maintained on tacrolimus twice daily. The efficacies,

safeties, and patient satisfaction for the two drugs at 6 months

post-transplantation were compared. RESULTS: Sixty patients were enrolled and

randomized to the investigational group (28 of 29 patients completed the study)

or the control group (26 of 31 patients completed the study). At 6 months

post-transplantation, composite efficacy failure rates including the incidences

of biopsy-confirmed acute rejection in the investigational and control groups

were 0% and 10.7%, respectively; patient survival was 100% in each group. No

difference in estimated glomerular filtration rate values were observed at 6

months post-transplantation (p=0.97). The safety and satisfaction profile

(immunosuppressant therapy barrier scale) of once-daily tacrolimus was comparable

with that of twice-daily tacrolimus (p=0.35). CONCLUSION: Conversion from

twice-daily tacrolimus to once-daily tacrolimus one month after transplantation

is safe and effective.