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https://hdl.handle.net/2440/35704
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Type: | Journal article |
Title: | FTY720/cyclosporine regimens in de novo renal transplantation: a 1-year dose-finding study |
Author: | Mulgaonkar, S. Tedesco, H. Oppenheimer, F. Walker, R. Kunzendorf, U. Russ, G. Knoflach, A. Patel, Y. Ferguson, R. |
Citation: | American Journal of Transplantation, 2006; 6(8):1848-1857 |
Publisher: | Blackwell Munksgaard |
Issue Date: | 2006 |
ISSN: | 1600-6143 1600-6143 |
Abstract: | FTY720 is a novel immunomodulator being investigated for rejection prophylaxis in renal transplantation when combined with full-dose cyclosporine (CsA; FDC). This 1-year phase II study compared FTY720 plus FDC (Neoral) with FTY720 plus reduced-dose CsA (RDC) and mycophenolate mofetil (MMF) plus FDC in de novo renal transplant patients. Patients were randomized 2:2:2:1 to FTY720 5 mg plus RDC (n = 72); FTY720 2.5 mg plus RDC (n = 74); FTY720 2.5 mg plus FDC (n = 76); or MMF plus FDC (n = 39) for 12 months. CsA exposure in the RDC group was reduced on average by 50% as assessed by C(2) monitoring. The primary efficacy endpoint was the composite incidence of biopsy-proven acute rejection (BPAR), graft loss, death or premature study discontinuation. The incidences for this composite endpoint were 24% and 22%, respectively, for FTY720 5 mg plus RDC and FTY720 2.5 mg plus FDC versus 39% for MMF plus FDC. Patients receiving FTY720 2.5 mg plus RDC were discontinued from treatment due to risk of under-immunosuppression. FTY720 2.5 mg plus FDC and FTY720 5 mg plus RDC were safe and effective in de novo renal transplant patients over 12 months. |
Keywords: | FTYA121 study group Lung Kidney Humans Sphingosine Propylene Glycols Cyclosporine Immunosuppressive Agents Biopsy Drug Therapy, Combination Kidney Transplantation Graft Rejection Dose-Response Relationship, Drug Time Factors Adult Middle Aged Female Male Drug-Related Side Effects and Adverse Reactions Fingolimod Hydrochloride |
DOI: | 10.1111/j.1600-6143.2006.01404.x |
Published version: | http://dx.doi.org/10.1111/j.1600-6143.2006.01404.x |
Appears in Collections: | Aurora harvest Medicine publications |
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