J Korean Soc Transplant.  2012 Dec;26(4):254-260. 10.4285/jkstn.2012.26.4.254.

Multicenter Clinical Investigation for the Safety and Efficacy of Advagraf(R) (Extended Release Tacrolimus) versus Prograf(R) (Tacrolimus) in De Novo Kidney Recipients after 1 Month of Transplantation: Preliminary Results

Affiliations
  • 1Department of Surgery, Ajou University School of Medicine, Suwon, Korea.
  • 2Department of Surgery, Yonsei University College of Medicine, Seoul, Korea. YUKIM@yuhs.ac
  • 3Department of Nephrology, University of Ulsan College of Medicine, Ulsan, Korea.
  • 4Department of Surgery, University of Ulsan College of Medicine, Ulsan, Korea.

Abstract

BACKGROUND
Compliance from kidney transplant recipients might improve with less frequent doses of immunosuppressant drugs. We describe the development of an extended-release formulation of tacrolimus that enables taking the drug just once a day, instead of the current twice a day tacrolimus formulation.
METHODS
We performed a prospective, open-label, 1:1 randomized, and multicenter study. Patients received Prograf(R) (Astellas Inc.) twice a day for 1 month post-transplantation. The patients of the investigational group converted to a dose of Advagraf(R) (Astellas Inc.) given once a day. We evaluated the efficacy, safety, and patient satisfaction of both groups.
RESULTS
Within 5 months after conversion to Advagraf, the incidence of biopsy-confirmed acute rejection was 0%, while patient and graft survival was 100%. We could not find differences of the patients' estimated glomerular filtration rate (eGFR) between the Prograf and Advagraf treated groups 1~6 months post-transplantation. The safety profile and satisfaction profiles (immunosuppressant therapy barrier scale) were also equivalent between the treated groups.
CONCLUSIONS
The preliminary results of this study support the safety, efficacy, and patient satisfaction from a single daily formulation of tacrolimus (Advagraf(R)).

Keyword

Kidney transplantation; Immunosuppression; Extended-release tacrolimus; Kidney graft function; Rejection
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