LCP-Tacro tacrolimus: Phase III data

The double-blind, double-dummy, international Phase III Study 3002 in 543 de novo kidney transplant recipients showed that once-daily LCP-Tacro met the primary endpoint of non-inferiority to twice-daily Prograf tacrolimus on a composite of biopsy-proven acute rejection, graft failure, death or loss to follow-up at 12 months (18.3% vs. 19.6%). Veloxis said the pre-specified non-inferiority margin was 10%. Rates of biopsy-proven acute rejection were 13.1% for LCP-Tacro vs. 13.5% for Prograf; rates of graft failure were 3.4% for LCP-Tacro vs. 4% for Prograf; rates of all-cause mortality were 3% for LCP-Tacro vs. 2.9% for Prograf; and rates of loss to follow-up were 1.5% for LCP-Tacro vs. 1.8% for Prograf. At 3 months, treatment failure rates were 10.4% for LCP-Tacro vs. 14.2% for Prograf (p=0.124). There were no significant differences between treatment groups in the incidence of adverse events or in pre-defined clinically significant laboratory measures, including fasting plasma glucose (FPG), platelet count, white blood cell count, aminotransaminases, total cholesterol, LDL-C, triglycerides or estimated glomerular filtration rate (eGFR). The company has an SPA from FDA for the trial. ...