61 216

Cited 0 times in

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
Authors
이, 종훈; 허, 규하; 이, 종수; 오, 창권; 조, 홍래; 김, 유선
Citation
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
ISSN
1598-1711
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.



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)).
Keywords
신장이식면역억제아드바그라프이식신기능거부반응Kidney transplantationImmunosuppressionExtended-release tacrolimusKidney graft functionRejection
Appears in Collections:
Journal Papers > School of Medicine / Graduate School of Medicine > Surgery
AJOU Authors
이, 종훈오, 창권
Files in This Item:
fulltext not available.txtDownload
Export
RIS (EndNote)
XLS (Excel)
XML

qrcode

해당 아이템을 이메일로 공유하기 원하시면 인증을 거치시기 바랍니다.

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.

Browse