The Clinical Studies
The FDA's approval of Prograf + MMF for use in kidney transplant recipients was based on the review of two clinical studies involving approximately 2,000 kidney transplant recipients. A phase III, multi-center, open-label clinical trial was conducted where 424 kidney transplant recipients received Prograf or cyclosporine in combination with MMF, basiliximab induction and corticosteroids. The study reported that the rate for the combined endpoint of biopsy proven acute rejection, graft failure, death and/or lost to follow-up at 12 months in the Prograf/MMF group was similar to the rate in the cyclosporine (CyA)/MMF group. There was, however, an imbalance in mortality at 12 months in those patients receiving Prograf/MMF (4.2%) compared to those receiving CyA/MMF (2.4%), including cases attributed to overimmunosuppression. This study was published in the March 2007 issue of the American Journal of Transplantation.
A second comparative clinical study was the ELITE-Symphony study, supported by Hoffmann La Roche, Inc. This study was a prospective, randomized, open-label, multicenter study in four parallel groups of kidney transplant recipients. The trial randomly assigned 1,589 kidney transplant recipients to receive standard dose CyA, MMF and corticosteroids (CS); or daclizumab induction, MMF and corticosteroids in combination with low-dose CyA, Prograf or sirolimus (Siro). The primary endpoint of the study was renal function, measured by estimated glomerular filtration rates (GFR), at 12 months after transplantation. Acute rejection, graft survival and overall mortality were also assessed as secondary endpoints. This study was published in the December 2007 issue of t
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