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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 Online, 2006; 6(8):1848-1857
Publisher: Blackwell Munksgaard
Issue Date: 2006
ISSN: 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
RMID: 0020062352
DOI: 10.1111/j.1600-6143.2006.01404.x
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