Introduction: Successful outcome in renal transplantation definitely depends on patient’s compliance with immunosuppressive medications. Compliance with complex immunosuppressive drugs might be improved with regimen that requires less frequent dosing, if the regimen would be safe and effective to prevent acute rejection. The purpose of this study is to compare the safety, efficacy, and patient satisfaction of once-a-day tacrolimus with twice-daily tacrolimus.

Methods: This prospective, randomized, open-label, multicenter study was conducted at three institutes. The patients of the investigational group were converted to the same daily dose of extended-release tacrolimus once a day AM after 1 month post-transplantation, while the patients in control group were kept the dosing of tacrolimus twice a day. We evaluated the efficacy, safety, and patient satisfaction of the groups within 6 months post-transplantation.

Results: Sixty patients were enrolled and randomized into the investigational group (28 of 29 patients completed the study follow-up) and the control group (26 of 31 patients completed the study follow-up). Within 5 months after conversion, the incidence of biopsy-confirmed acute rejection of the investigational group was 0%, compared with 10.7% of the control group; patient survival was 100% in each group. We could not find the differences of the patients’ eGFR at 6 months post-transplantation between the groups (P=0.97). The safety profile and satisfaction profile (Immunosuppressant Therapy Barrier Scale; ITBS) were consistent with the group of the twice-daily tacrolimus (P=0.35).

Conclusion: The results of this study support the safety, efficacy, and patient satisfaction of once-a-day tacrolimus, compared to twice-daily tacrolimus.

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