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Mizoribine Versus Mycophenolate Mofetil in Combination Therapy With Tacrolimus for De Novo Kidney Transplantation: Evaluation of Efficacy and Safety

Title
Mizoribine Versus Mycophenolate Mofetil in Combination Therapy With Tacrolimus for De Novo Kidney Transplantation: Evaluation of Efficacy and Safety
Authors
M.K. Ju;K.H. Huh;Y.S. Kim;D.J. Joo;S. Lee;C.M. Kang;B.J. So;C.D. Kim;B.H. Cho;S.J. Kim;K.T. Park
Issue Date
2013
Journal Title
Transplantation Proceedings
ISSN
0041-1345
Citation
Transplantation Proceedings, Vol.45(4) : 1481~1486, 2013
Abstract
The present study compared the efficacy and safety of mizoribine (MZR) with mycophenolate mofetil (MMF) in kidney transplantation. This multicenter, randomized clinical trial. Employed doses of study drug tailored to the immunosuppressive need. The primary efficacy outcome was the incidence of biopsy-proven acute rejection episodes (BPAR). The safety of the study drug was assessed using the incidences of adverse events, drug discontinuations, and abnormal laboratory results. The 7 (6.4%) BPARs above grade II were observed in the MZR group noninferior to the 2 (1.8%) in the MMF group (95% confidence interval, -0.007-0.097 > noninferiority limit [-0.2]). BPAR was significantly decreased in the MZR group after the dose change (17/41 [41.4%] vs 8/69 [11.6%]; P < .0001) and the incidence of BPAR was similar between the MZR and MMF groups after the dose change (P = .592). The uric acid level was significantly elevated in the MZR group (P = .002). In conclusion, the efficacy and safety of MZR were similar and statistically noninferior to MMF in combination therapy with tacrolimus.
URI
http://www.sciencedirect.com/science/article/pii/S0041134513000857

http://ir.ymlib.yonsei.ac.kr/handle/22282913/87021
DOI
10.1016/j.transproceed.2012.12.028
Appears in Collections:
1. 연구논문 > 1. College of Medicine > Dept. of Surgery
Yonsei Authors
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