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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| Authors: | H. Tedesco-Silva M.I. Lorber C.E. Foster H.W. Sollinger R. Mendez D.B. Carvalho R. Shapiro P.R. Rajagopalan H. Mayer J. Slade B.D. Kahan for the FTYA clinical study group |
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| Affiliation: | Hospital do Rim Hipertensão/UNIFESP, Setor de Transplante Renal, Sao Paulo, Brazil;, Section of Organ Transplantation and Immunology, Yale University School of Medicine, New Haven, CT, USA;, UCI Medical Center, Orange, CA, USA;, University of Wisconsin, Madison, WI, USA;, National Institute of Transplantation, Los Angeles, CA, USA;, Hospital Geral de Bonsucesso, Unidad de Transplant Renal, Rio de Janeiro, Brazil;, Thomas E. Starzl Transplantation Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA;, Medical University of South Carolina, Charleston, SC, USA;, Novartis Pharma AG, Basel, Switzerland;, Novartis Pharmaceutical Corporation, East Hanover, NJ, USA;and University of Texas Medical School, Houston, TX, USA |
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| Abstract: | 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. |
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| Keywords: | CNI-free regimen delayed graft function everolimus FTY720 renal transplantation |
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