title: 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: OBJECTIVE
  The purpose of this study was to compare once-daily tacrolimus with twice-daily tacrolimus in terms of safety, efficacy, and patient satisfaction.
  
  
  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).
  
  
  CONCLUSIONS
  Conversion from twice-daily tacrolimus to once-daily tacrolimus one month after transplantation is safe and effective.
authors.affiliation: Department of Surgery, Ajou University School of Medicine, Suwon, Korea.
authors.forename: Chang-Kwon
authors.initials: CK
authors.lastname: Oh
authors.affiliation: Department of Transplantation Surgery, Severance Hospital, Yonsei University Health System, Seoul, Korea.
authors.forename: Kyu Ha
authors.initials: KH
authors.lastname: Huh
authors.affiliation: Department of Nephrology, University of Ulsan College of Medicine, Ulsan, Korea.
authors.forename: Jong Soo
authors.initials: JS
authors.lastname: Lee
authors.affiliation: Department of Surgery, University of Ulsan College of Medicine, Ulsan, Korea.
authors.forename: Hong Rae
authors.initials: HR
authors.lastname: Cho
authors.affiliation: Department of Transplantation Surgery, Severance Hospital, Yonsei University Health System, Seoul, Korea. yukim@yuhs.ac.
authors.forename: Yu Seun
authors.initials: YS
authors.lastname: Kim
mesh_terms: D000328:Adult; D004334:Drug Administration Schedule; D005260:Female; D006084:Graft Rejection / Q000188:drug therapy / Q000517:prevention & control; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D012449:Safety; D016559:Tacrolimus / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D007166:Immunosuppressive Agents; D016559:Tacrolimus
keywords: Acute rejection; efficacy; extended-release tacrolimus; kidney transplantation; safety