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

par Hoitsma, Andries;Woodle, Ervin Steve;Abramowicz, Daniel ;Proot, Pieter;Vanrenterghem, Yves
Référence Nephrology, dialysis, transplantation, 26, 11, page (3802-3805)
Publication Publié, 2011-11

Article révisé par les pairs

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Résumé :

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. © The Author 2011. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.