Safety and Efficacy of Conversion from Twice-Daily Tacrolimus to Once-Daily Tacrolimus One Month after Transplantation: Randomized Controlled Trial in Adult Renal Transplantation
Yonsei Medical Journal
;
: 1341-1347, 2014.
Article
in English
| WPRIM
| ID: wpr-44332
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 ANDMETHODS:
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Safety
/
Drug Administration Schedule
/
Kidney Transplantation
/
Tacrolimus
/
Graft Rejection
/
Immunosuppressive Agents
Type of study:
Controlled clinical trial
Limits:
Adult
/
Female
/
Humans
/
Male
Language:
English
Journal:
Yonsei Medical Journal
Year:
2014
Type:
Article
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