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dc.contributor.authorTedesco-Silva, Helio [UNIFESP]
dc.contributor.authorPeddi, V. Ram
dc.contributor.authorSanchez-Fructuoso, Ana
dc.contributor.authorMarder, Brad A.
dc.contributor.authorRuss, Graeme R.
dc.contributor.authorDiekmann, Fritz
dc.contributor.authorFlynn, Alison
dc.contributor.authorHahn, Carolyn M.
dc.contributor.authorLi, Huihua
dc.contributor.authorTortorici, Michael A.
dc.contributor.authorSchulman, Seth L.
dc.identifier.citationTransplantation Direct. Philadelphia, v. 2, n. 4, p. -, 2016.
dc.description.abstractBackground. Calcineurin inhibitor-associated nephrotoxicity and other adverse events have prompted efforts to minimize/eliminate calcineurin inhibitor use in kidney transplant recipients. Methods. This open-label, randomized, multinational study evaluated the effect of planned transition from tacrolimus to sirolimus on kidney function in renal allograft recipients. Patients received tacrolimus-based immunosuppression and then were randomized 3 to 5 months posttransplantation to transition to sirolimus or continue tacrolimus. The primary end point was percentage of patients with 5 mL/min per 1.73 m(2) or greater improvement in estimated glomerular filtration rate from randomization to month 24. Results. The on-therapy population included 195 patients (sirolimus, 86en
dc.description.abstracttacrolimus, 109). No between-group difference was noted in percentage of patients with 5 mL/min per 1.73 m(2) or greater estimated glomerular filtration rate improvement (sirolimus, 34%en
dc.description.abstracttacrolimus, 42%en
dc.description.abstractP = 0.239) at month 24. Sirolimus patients had higher rates of biopsy-confirmed acute rejection (8% vs 2%en
dc.description.abstractP = 0.02), treatment discontinuation attributed to adverse events (21% vs 3%en
dc.description.abstractP < 0.001), and lower rates of squamous cell carcinoma of the skin (0% vs 5%en
dc.description.abstractP = 0.012). Conclusions. Our findings suggest that renal function improvement at 24 months is similar for patients with early conversion to sirolimus after kidney transplantation versus those remaining on tacrolimus.en
dc.description.sponsorshipBristol-Myers Squibb
dc.publisherLippincott Williams & Wilkins
dc.relation.ispartofTransplantation Direct
dc.rightsAcesso aberto
dc.titleOpen-Label, Randomized Study of Transition From Tacrolimus to Sirolimus Immunosuppression in Renal Allograft Recipientsen
dc.description.affiliationHosp Rim, Div Nefrol, Sao Paulo, Brazil
dc.description.affiliationCalif Pacific Med Ctr, Dept Transplantat, San Francisco, CA USA
dc.description.affiliationHosp Clin San Carlos, Dept Nephrol, Madrid, Spain
dc.description.affiliationSt Lukes Med Ctr, Internal Med & Nephrol, Denver, CO USA
dc.description.affiliationRoyal Adelaide Hosp, Renal & Transplant Serv, Adelaide, SA, Australia
dc.description.affiliationHosp Clin Barcelona, Dept Nephrol & Renal Transplantat, Barcelona, Spain
dc.description.affiliationPfizer, Global Innovat Pharma, Collegeville, PA USA
dc.description.affiliationCSL Behring Biotherapies Life Clin Pharmacol & Ph, King Of Prussia, PA USA
dc.description.affiliationUnifespHosp Rim, Div Nefrol, Sao Paulo, Brazil
dc.description.sourceWeb of Science

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