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

Hoitsma, Andries J.; Woodle, Ervin S.; Abramowicz, Daniel; Proot, Pieter; Vanrenterghem, Yves

doi:10.1093/NDT/GFR503

Title

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

Author

Hoitsma, Andries J.

Woodle, Ervin S.

Abramowicz, Daniel

Proot, Pieter

Vanrenterghem, Yves

Institution/Organisation

FTY720 Phase II Transplant Study G

Abstract

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.

Language

English

Source (journal)

Nephrology, dialysis, transplantation. - Berlin

Publication

Berlin : 2011

ISSN

0931-0509

DOI

10.1093/NDT/GFR503

Volume/pages

26 :11 (2011) , p. 3802-3805