FTY720 and everolimus in de novo renal transplant patients at risk for delayed graft function: results of an exploratory one-yr multicenter study

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dc.contributor.author Tedesco-Silva, H. [UNIFESP]
dc.contributor.author Lorber, M. I.
dc.contributor.author Foster, C. E.
dc.contributor.author Sollinger, H. W.
dc.contributor.author Mendez, R.
dc.contributor.author Carvalho, D. B.
dc.contributor.author Shapiro, R.
dc.contributor.author Rajagopalan, P. R.
dc.contributor.author Mayer, H.
dc.contributor.author Slade, J.
dc.contributor.author Kahan, B. D.
dc.contributor.author FTY720A2202 Clinical Study Grp
dc.date.accessioned 2016-01-24T13:58:44Z
dc.date.available 2016-01-24T13:58:44Z
dc.date.issued 2009-09-01
dc.identifier http://dx.doi.org/10.1111/j.1399-0012.2009.01070.x
dc.identifier.citation Clinical Transplantation. Malden: Wiley-Blackwell Publishing, Inc, v. 23, n. 5, p. 589-599, 2009.
dc.identifier.issn 0902-0063
dc.identifier.uri http://repositorio.unifesp.br/handle/11600/31800
dc.description.abstract This exploratory, multicenter, open-label study evaluated the efficacy and safety of FTY720, as a part of an immunosuppressive regimen, in combination with everolimus and steroids in de novo renal transplant recipients at increased risk of delayed graft function (DGF). Patients received FTY720 (5 mg) and everolimus (4 mg) 2-12 h pre-transplantation, followed by 2.5 mg/d FTY720 and concentration-controlled everolimus (4-8 ng/mL) post-transplant for 12 months. Induction therapy was prohibited. After enrollment of 56 of the planned 200 patients between 2000 and 2002, the recruitment was terminated. the primary endpoint, rate of graft loss, or death at three months was 15.4% and the biopsy-confirmed acute rejection was 42.3%. Death or graft loss at 12 months in the DGF and non-DGF arms was 36.0% and 25.9%, respectively. the mean estimated creatinine clearance at three months was 63 and 55 mL/min in the non-DGF and DGF groups, respectively, while at 12 months it was 56 mL/min in both the groups. Although there was no comparator arm, the results from this exploratory study (compared with data from other phases II and III trials) indicated no apparent benefits of FTY720-based regimens for prevention of acute rejection and preservation of renal function in renal transplant recipients at high risk of DGF. en
dc.format.extent 589-599
dc.language.iso eng
dc.publisher Wiley-Blackwell
dc.relation.ispartof Clinical Transplantation
dc.rights Acesso restrito
dc.subject CNI-free regimen en
dc.subject delayed graft function en
dc.subject everolimus en
dc.subject FTY720 en
dc.subject renal transplantation en
dc.title FTY720 and everolimus in de novo renal transplant patients at risk for delayed graft function: results of an exploratory one-yr multicenter study en
dc.type Artigo
dc.rights.license http://olabout.wiley.com/WileyCDA/Section/id-406071.html
dc.contributor.institution Universidade Federal de São Paulo (UNIFESP)
dc.contributor.institution Yale Univ
dc.contributor.institution UCI Med Ctr
dc.contributor.institution Univ Wisconsin
dc.contributor.institution Natl Inst Transplantat
dc.contributor.institution Hosp Geral Bonsucesso
dc.contributor.institution Univ Pittsburgh
dc.contributor.institution Med Univ S Carolina
dc.contributor.institution Novartis Pharma AG
dc.contributor.institution Novartis Pharmaceut
dc.contributor.institution Univ Texas Med Sch
dc.description.affiliation Hosp Rim Hipertensao UNIFESP, Setor Transplante Renal, BR-04038002 São Paulo, Brazil
dc.description.affiliation Yale Univ, Sch Med, Sect Organ Transplantat & Immunol, New Haven, CT USA
dc.description.affiliation UCI Med Ctr, Orange, CA USA
dc.description.affiliation Univ Wisconsin, Madison, WI USA
dc.description.affiliation Natl Inst Transplantat, Los Angeles, CA USA
dc.description.affiliation Hosp Geral Bonsucesso, Unidad Transplant Renal, Rio de Janeiro, Brazil
dc.description.affiliation Univ Pittsburgh, Med Ctr, Thomas E Starzl Transplantat Inst, Pittsburgh, PA USA
dc.description.affiliation Med Univ S Carolina, Charleston, SC 29425 USA
dc.description.affiliation Novartis Pharma AG, Basel, Switzerland
dc.description.affiliation Novartis Pharmaceut, E Hanover, NJ USA
dc.description.affiliation Univ Texas Med Sch, Houston, TX USA
dc.description.affiliationUnifesp Hosp Rim Hipertensao UNIFESP, Setor Transplante Renal, BR-04038002 São Paulo, Brazil
dc.identifier.doi 10.1111/j.1399-0012.2009.01070.x
dc.description.source Web of Science
dc.identifier.wos WOS:000270397100003


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