Advagraf tacrolimus: Phase IIIb data

The open-label, international Phase IIIb OSAKA trial in 1,251 adult kidney transplant patients showed that 0.2 mg/kg/day Advagraf once daily was non-inferior to the same daily dose of twice-daily Prograf tacrolimus over 6 months in the per protocol population on the primary endpoint of efficacy failure rate (42.2% vs. 40.6%). Efficacy failure rates for 0.3 mg/kg/day Advagraf or 0.2 mg/kg/day Advagraf plus Simulect basiliximab in the per protocol population were 44.2% and 48.2%. Non-inferiority also was established in the full analysis set for patients receiving 0.3 mg/kg/day Advagraf vs. 0.2 mg/kg/day Prograf. The pre-specified non-inferiority margin was 12.5%.

Incidence, time to first incidence and severity of BCAR were comparable across treatment arms. There were 2 deaths possibly related to study medication. Data were presented at the American Transplant Congress in Philadelphia. ...