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

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Ⓡ (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Ⓡ).