FTY720/Cyclosporine Regimens in De Novo Renal Transplantation: A 1‐Year Dose‐Finding Study

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 C2 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.

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