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

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

Author Tedesco-Silva, H. Autor UNIFESP Google Scholar
Lorber, M. I. Google Scholar
Foster, C. E. Google Scholar
Sollinger, H. W. Google Scholar
Mendez, R. Google Scholar
Carvalho, D. B. Google Scholar
Shapiro, R. Google Scholar
Rajagopalan, P. R. Google Scholar
Mayer, H. Google Scholar
Slade, J. Google Scholar
Kahan, B. D. Google Scholar
FTY720A2202 Clinical Study Grp Google Scholar
Institution Universidade Federal de São Paulo (UNIFESP)
Yale Univ
UCI Med Ctr
Univ Wisconsin
Natl Inst Transplantat
Hosp Geral Bonsucesso
Univ Pittsburgh
Med Univ S Carolina
Novartis Pharma AG
Novartis Pharmaceut
Univ Texas Med Sch
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.
Keywords CNI-free regimen
delayed graft function
everolimus
FTY720
renal transplantation
Language English
Date 2009-09-01
Published in Clinical Transplantation. Malden: Wiley-Blackwell Publishing, Inc, v. 23, n. 5, p. 589-599, 2009.
ISSN 0902-0063 (Sherpa/Romeo, impact factor)
Publisher Wiley-Blackwell
Extent 589-599
Origin http://dx.doi.org/10.1111/j.1399-0012.2009.01070.x
Access rights Closed access
Type Article
Web of Science ID WOS:000270397100003
URI http://repositorio.unifesp.br/handle/11600/31800

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