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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

Other Title
신장이식 1개월 이후 Advagraf(R) (Extended Release Tacrolimus)와 Prograf(R) (Tacrolimus)의 유효성 및 안전성을 비교 평가하기 위한 공개, 평행, 다기관 임상시험: 중간 연구 보고
이, 종훈; 허, 규하; 이, 종수; 오, 창권; 조, 홍래; 김, 유선
Taehan Isik Hakhoe chi, 26(4):254-260, 2012
Journal Title
Taehan Isik Hakhoe chi; The journal of the Korean Transplantation Society; Journal of the Korean Society for Transplantation; 대한이식학회지
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.

Result: 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)).
신장이식면역억제아드바그라프이식신기능거부반응Kidney transplantationImmunosuppressionExtended-release tacrolimusKidney graft functionRejection
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Journal Papers > School of Medicine / Graduate School of Medicine > Surgery
AJOU Authors
이, 종훈오, 창권
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