Conversion of stable renal transplant recipients from sandimmune to sang-35, a novel cyclosporine formulation, using a dose-normalized equivalence method

Abstract

CONSIDERABLE interindividual and intraindividual variability has been reported with the use of cyclosporine in solid organ transplant recipients. A number of studies have reported an increased incidence of both acute rejection and chronic rejection in individuals with low cyclosporine bioavailability. The introduction of the microemulsion formulation of cyclosporine (Neoral) has resulted in less pharmacokinetic variability when compared to the original Sandimmune formulation. Patients converted from Sandimmune to Neoral have a significantly improved coefficient of variation for three key pharmacokinetic parameters, namely maximum concentration (Cmax), time to maximum concentration (Tmax), and the area under the concentration-versus time curve (AUC). We have previously reported that a novel cyclosporine formulation, Sang-35 (SangStat Medical Corporation, Menlo Park, Calif.), is equivalent to Neoral in healthy males, females, Caucasians, and African-Americans and under fed and fasted conditions. This study was designed to evaluate the safety and efficacy of conversion from Sandimmune to Sang-35 in stable adult renal allograft recipients.