신장이식 1개월 이후 AdvagrafⓇ (Extended Release Tacrolimus)와
PrografⓇ (Tacrolimus)의 유효성 및 안전성을 비교 평가하기 위한 공개, 평행,
다기관 임상시험: 중간 연구 보고
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 ; 김유선 ; 조홍래 ; 오창권 ; 이종수
대한이식학회지, Vol.26(4) : 254~260, 2012
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Ⓡ).