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FTY720/cyclosporine regimens in de novo renal transplantation: a 1-year dose-finding study

S Mulgaonkar1, H Tedesco, F Oppenheimer

  • 1Saint Barnabas Medical Center, Livingston, New Jersey, USA. smulgaonkar@sbhcs.com

American Journal of Transplantation : Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons
|June 15, 2006
PubMed

Insights

FTY720 combined with full-dose cyclosporine (FDC) demonstrated safety and efficacy in de novo renal transplant patients. This immunomodulator offers a promising alternative for rejection prophylaxis over 12 months.

Area of Science:

  • Nephrology
  • Immunology
  • Pharmacology

Background:

  • Renal transplantation requires effective immunosuppression to prevent graft rejection.
  • Novel immunomodulators are being investigated to optimize rejection prophylaxis.
  • Cyclosporine (CsA) is a standard immunosuppressant, but its full dose can have toxicity concerns.

Purpose of the Study:

  • To compare the efficacy and safety of FTY720 combined with full-dose CsA (FDC) versus reduced-dose CsA (RDC) and mycophenolate mofetil (MMF) plus FDC in de novo renal transplant patients.
  • To evaluate FTY720's role in preventing acute rejection, graft loss, or death.
  • To assess the safety profile of FTY720-based regimens.

Main Methods:

  • A 1-year, phase II, randomized study in de novo renal transplant patients.
  • Four treatment arms: FTY720 5 mg + RDC, FTY720 2.5 mg + RDC, FTY720 2.5 mg + FDC, and MMF + FDC.
  • CsA exposure monitored by C(2) levels, with RDC achieving approximately 50% reduction.
  • Primary endpoint: composite incidence of biopsy-proven acute rejection (BPAR), graft loss, death, or discontinuation.

Main Results:

  • FTY720 5 mg + RDC (24%) and FTY720 2.5 mg + FDC (22%) showed significantly lower composite endpoint incidence compared to MMF + FDC (39%).
  • FTY720 2.5 mg + RDC arm was discontinued due to under-immunosuppression risk.
  • FTY720 2.5 mg + FDC and FTY720 5 mg + RDC regimens were found to be safe and effective over 12 months.

Conclusions:

  • FTY720 in combination with either full-dose or reduced-dose CsA (with dose adjustments) is safe and effective for de novo renal transplant patients.
  • FTY720 2.5 mg + FDC and FTY720 5 mg + RDC represent viable options for immunosuppression in renal transplantation.
  • Careful monitoring and dose selection are crucial when using FTY720 with reduced-dose CsA to avoid under-immunosuppression.

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