Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2011
FTY720 combined with tacrolimus in de novo renal transplantation: 1-year, multicenter, open-label randomized study.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Hoitsma Andries J, Woodle Ervin S, Abramowicz Daniel, Proot Pieter, Vanrenterghem Yves, FTY720 Phase II Transplant Study Group
Аннотация
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.
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.
Предметные рубрики MeSH
AdolescentAdultAgedCyclosporineDrug Therapy, CombinationFemaleFingolimod HydrochlorideFollow-Up StudiesGlomerular Filtration RateGraft RejectionHumansImmunosuppressive AgentsKidney Failure, ChronicKidney Function TestsKidney TransplantationMaleMiddle AgedMycophenolic AcidPrognosisPropylene GlycolsSphingosineSurvival RateTacrolimusYoung Adult