FTY720 combined with tacrolimus in de novo renal transplantation: 1-year, multicenter, open-label randomized study

被引:35
作者
Hoitsma, Andries J. [1 ]
Woodle, Ervin S. [2 ]
Abramowicz, Daniel [3 ]
Proot, Pieter [4 ]
Vanrenterghem, Yves [5 ]
机构
[1] Radboud Univ Nijmegen, Med Ctr, Dept Nephrol, NL-6525 ED Nijmegen, Netherlands
[2] Univ Cincinnati, Div Transplantat, Cincinnati, OH USA
[3] Free Univ Brussels, Hop Erasme, Dept Nephrol, B-1070 Brussels, Belgium
[4] Novartis Pharma AG, Dev, Basel, Switzerland
[5] Univ Hosp Gasthuisberg, Dept Nephrol, B-3000 Louvain, Belgium
关键词
FTY720; mycophenolate mofetil; renal transplantation; sphingosine 1-phosphate receptor; tacrolimus; CONTROLLED-TRIAL; REGIMENS; MMF;
D O I
10.1093/ndt/gfr503
中图分类号
R3 [基础医学]; R4 [临床医学];
学科分类号
1001 ; 1002 ; 100602 ;
摘要
Background. FTY720 (fingolimod), a novel immunomodulator, has demonstrated potential for prevention of acute rejection in combination with cyclosporine. Methods. This study evaluated FTY720 2.5 mg versus mycophenolate mofetil (MMF) in a combination regimen with standard tacrolimus and corticosteroids in de novo renal transplant recipients for the composite efficacy within 6 months of transplantation. Results. Incidence of treated biopsy-proven acute rejection was 22.9% with FTY720 and 18.5% with MMF. Increased incidence of macular oedema, transient decrease in heart rate and low rate of infections were seen in the FTY720 arm. Conclusion. FTY720 combined with tacrolimus and steroids did not show a significant therapeutic advantage over MMF for the prevention of acute rejection in de novo renal transplant recipients.
引用
收藏
页码:3802 / 3805
页数:5
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