Astellas Pharma Europe Ltd today announced that the results of the 6-month OSAKA study demonstrate that tacrolimus prolonged release (QD; ADVAGRAF(R), Graceptor(R) in Japan)-based therapy is non-inferior to the same daily dose of tacrolimus immediate release (BID; PROGRAF(TM))-based therapy (0.2mg/kg/day) for efficacy in renal transplantation. These data were presented for the first time this week at the 2011 American Transplant Congress in Philadelphia.

In an era when there are few promising new immunosuppressants in the pipeline for kidney transplantation, the OSAKA study investigated how to optimise exposure to tacrolimus QD in comparison with the current clinical standard, tacrolimus BID.

The study was conducted in 110 centres across 22 countries, and included more than 1,200 patients. Patients and donors reflected the real-life clinical situation, with recognised declining organ quality and an ageing patient population. Approximately two-thirds of patients in the study were male and mean age was around 50 years. The mean age of organ donors in the study was 51.5 years and approximately 50% were defined as extended criteria donors.

At 6 months, efficacy comparison revealed no significant difference between treatment arms in the primary composite endpoint of efficacy failure. Graft dysfunction (measured at the study end) was the primary cause of efficacy failure in all treatment arms. The level of estimated glomerular filtration rate (eGFR) set for graft dysfunction (

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