Safety and Efficacy of Conversion from Twice-Daily Tacrolimus to Once-Daily Tacrolimus One Month after Transplantation: Randomized Controlled Trial in Adult Renal Transplantation.
10.3349/ymj.2014.55.5.1341
- Author:
Chang Kwon OH
1
;
Kyu Ha HUH
;
Jong Soo LEE
;
Hong Rae CHO
;
Yu Seun KIM
Author Information
1. Department of Surgery, Ajou University School of Medicine, Suwon, Korea.
- Publication Type:Original Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
- Keywords:
Acute rejection;
efficacy;
extended-release tacrolimus;
kidney transplantation;
safety
- MeSH:
Adult;
Drug Administration Schedule;
Female;
Graft Rejection/drug therapy/prevention & control;
Humans;
Immunosuppressive Agents/*administration & dosage/adverse effects/therapeutic use;
*Kidney Transplantation;
Male;
Middle Aged;
Safety;
Tacrolimus/*administration & dosage/adverse effects/therapeutic use
- From:Yonsei Medical Journal
2014;55(5):1341-1347
- CountryRepublic of Korea
- Language:English
-
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.
