Novel Once-Daily Extended-Release Tacrolimus Versus Twice-Daily Tacrolimus in De Novo Kidney Transplant Recipients: Two-Year Results of Phase 3, Double-Blind, Randomized Trial
Rostaing L, Bunnapradist S, Grinyó J, Ciechanowski K, Denny J, Silva H, Budde K, Group E, Denny J, Kulkarni S, Hricik D, Bresnahan B, Bunnapradist S, El-Sabrout R, Chan L, Ciancio G, El-Ghoroury M, Goldstein M, Gaston R, Gohh R, Killackey M, King A, Knight R, Kore A, Sudan D, Friedmann J, Mulgaonkar S, Nolan C, Pankewycz O, Pirsch J, Schaefer H, Steinberg S, Gelb B, True K, West-Thielke P, Waybill M, Wolf J, Ketel B, Harland R, Shihab F, Cassuto E, Le Meur Y, Rostaing L, Mariat C, Grinyó J, Puig J, Seron D, Tisone G, Ciechanowski K, Foroncewicz B, Wlodarczyk Z, Budde K, Witzke O, Mondragon G, Urrea E, Gomez J, Acevedo R, del Carmen Rial M, Novoa P, Silva H, Garcia V, Carvalho D, Saber L, Contieri F, Bastos M, Manfro R, Kanellis J, Eris J, O’Connell P, Hughes P, Russ G, Pidgeon G, Dittmer I, Kee T, Vathsala A, Naumovic R, Mitic I, Parmjeet R. Novel Once-Daily Extended-Release Tacrolimus Versus Twice-Daily Tacrolimus in De Novo Kidney Transplant Recipients: Two-Year Results of Phase 3, Double-Blind, Randomized Trial. American Journal Of Kidney Diseases 2015, 67: 648-659. PMID: 26717860, DOI: 10.1053/j.ajkd.2015.10.024.Peer-Reviewed Original ResearchConceptsTotal daily doseDe novo kidney transplant recipientsNovo kidney transplant recipientsKidney transplant recipientsIR-TacKidney transplantationTransplant recipientsAdverse eventsTreatment failureDaily extended-release tacrolimusDe novo kidney transplantationMean total daily doseLower total daily doseExtended-release tacrolimusOnce-Daily ExtendedTarget trough rangesTwice-Daily TacrolimusNew-onset diabetesSafety end pointSerious adverse eventsPhase 3 trialImmediate-release tacrolimusParticipant eligibility criteriaTwo-year resultsImproved bioavailability
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