FTY720 combined with tacrolimus in de novo renal transplantation: 1-year, multicenter, open-label randomized study.
Hoitsma AJ. Woodle ES. et al.Nephrology Dialysis Transplantation. 26(11): 3802-5, 2011.
Aims
To compare the efficacy of FTY720 with mycophenolate mofetil (MMF) in a combination regimen with standard tacrolimus and corticosteroids in de novo renal transplant recipients.
Interventions
FTY720 versus MMF. All patients received tacrolimus and steroids.
Participants
103 patients who received a primary cadaveric or living donor renal transplant.
Outcomes
Primary efficacy outcome was the composite of treated biopsy-proven acute rejection, graft loss, death or premature study discontinuation within 6 months post-transplantation. Safety assessments included macular edema and bronchodilator reversibility testing.
Follow-up
2 years
CET Conclusions
FTY720 combined with tacrolimus and steroids did not show any therapeutic advantage over tacrolimus and MMF in the prevention of acute rejection. This study was discontinued earlier than planned as the sponsor had terminated the FTY720 directed development program in transplantation.
Data analysis
Modified intention-to-treat analysis
Trial registration
NCT00239876 (ClinicalTrials.gov)