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신장이식 1개월 이후 AdvagrafⓇ (Extended Release Tacrolimus)와 PrografⓇ (Tacrolimus)의 유효성 및 안전성을 비교 평가하기 위한 공개, 평행, 다기관 임상시험: 중간 연구 보고

Other Titles
 Multicenter Clinical Investigation for the Safety and Efficacy of Advagraf® (Extended Release Tacrolimus) versus Prograf® (Tacrolimus) in De Novo Kidney Recipients after 1 Month of Transplantation: Preliminary Results 
 이종훈  ;  허규하  ;  이종수  ;  오창권  ;  조홍래  ;  김유선 
 Journal of the Korean Society for Transplantation (대한이식학회지), Vol.26(4) : 254-260, 2012 
Journal Title
 Journal of the Korean Society for Transplantation (대한이식학회지) 
Issue Date
Kidney transplantation ; Immunosuppression ; Extended-release tacrolimus ; Kidney graft function ; Rejection
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Ⓡ (Astellas Inc.) twice a day for 1 month post-transplantation. The patients of the investigational group converted to a dose of AdvagrafⓇ (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Ⓡ).
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1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Yu Seun(김유선) ORCID logo https://orcid.org/0000-0002-5105-1567
Cho, Hong Rae(조홍래)
Huh, Kyu Ha(허규하) ORCID logo https://orcid.org/0000-0003-1364-6989
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