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A 6-month, open-label, multicenter clinical study in Korean de novo renal transplant patients evaluating the efficacy, safety, and tolerance of myfortic concomitantly used with tacrolimus

Authors
 M.K. Ju  ;  S.H. Park  ;  Y.S. Kim  ;  I.S. Moon  ;  S.J. Kim 
Citation
 Transplantation Proceedings, Vol.44(1) : 144-146, 2012 
Journal Title
 Transplantation Proceedings 
ISSN
 0041-1345 
Issue Date
2012
Abstract
Enteric-coated mycophenolate sodium (myfortic, Novartis Pharma AG, Basel, Switzerland) is designed to improve the gastrointestinal tolerability of micophenolic acid. This study was designed to evaluate the efficacy and safety of myfortic in Korean de novo renal transplantation. A total of 65 patients from four transplantation centers received the study drug at least once and were included in the intention-to-treat analysis. This study was an open-label, single-arm, multicenter trial with 6-month patient follow-up. Patients received 360 mg (body weight < 50 kg) or 720 mg (body weight > 50 kg) of myfortic per day with tacrolimus and steroids. Induction therapy included basiliximab. The incidence of biopsy-confirmed acute rejection (primary endpoint) within 6 months after transplantation was 7/65 (10.8%). There were 2 (3.1%) graft losses due to severe acute rejection and 1 (1.5%) patient-death due to cardiac arrest. Twenty-two (38.8%) patients experienced gastrointestinal discomfort; however, only 3 (4.5%) cases were associated with an apparent drug reaction. Seventeen (25.4%) patients underwent dose adjustment or myfortic discontinuation during the study period. Patient and graft survival rates at 6 months posttransplantation were 98.1% and 97.0%. Myfortic with tacrolimus-based immunosuppression was efficient and safe after de novo renal transplantation in Korean patients.
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/91955
DOI
10.1016/j.transproceed.2011.12.015
Appears in Collections:
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실)
Yonsei Authors
김유선(Kim, Yu Seun) ; 주만기(Joo, Man Ki)
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Full Text
http://www.sciencedirect.com/science/article/pii/S0041134511016770
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