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.
10.4285/jkstn.2012.26.4.254
- Author:
Jong Hoon LEE
1
;
Kyu Ha HUH
;
Jong Soo LEE
;
Chang Kwon OH
;
Hong Rae CHO
;
Yu Seun KIM
Author Information
1. Department of Surgery, Ajou University School of Medicine, Suwon, Korea.
- Publication Type:Multicenter Study ; Original Article ; Randomized Controlled Trial
- Keywords:
Kidney transplantation;
Immunosuppression;
Extended-release tacrolimus;
Kidney graft function;
Rejection
- MeSH:
Compliance;
Glomerular Filtration Rate;
Graft Survival;
Humans;
Immunosuppression;
Incidence;
Kidney;
Kidney Transplantation;
Patient Satisfaction;
Prospective Studies;
Rejection (Psychology);
Tacrolimus
- From:The Journal of the Korean Society for Transplantation
2012;26(4):254-260
- CountryRepublic of Korea
- Language:Korean
-
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)).
