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CellCept(R) and a Reduced Level of CNI Shows Trend Towards Preservation of Kidney Function Versus a Standard-Dose CNI
Date:6/4/2008

TORONTO, June 4 /PRNewswire/ -- The 12-month results from a multicenter trial monitoring CellCept(R) (mycophenolate mofetil) in combination with calcineurin inhibitors (CNIs) in renal transplantation was presented today at the American Transplant Congress (ATC). The study results showed that a reduced level of CNI with a therapeutic monitored dose of CellCept is not inferior to that of a fixed dose of CellCept, and the standard-dose of CNI as it relates to biopsy-proven acute rejection (BPAR) and other end points.

The lower CNI dose regimen studied to avoid long-term side effects of chronic administration of CNI, facilitated a higher CellCept dosing without an overall increase in adverse events, and with a trend toward preservation of kidney function versus the standard-dose CNI regimens. As transplant patients are living longer, studies suggest that therapies such as CNIs can cause impairment of kidney function, damage to the blood vessels, and filtering capacity of the kidneys.

"The Opticept trial was designed to examine the impact of monitored CellCept dosing to enable a low dose CNI regimen with fewer complications and preservation of efficacy in preventing rejection," said Robert Gaston, M.D., lead investigator, University of Alabama at Birmingham, Birmingham, AL. "The 12-month study results are very encouraging and additional follow-up may provide insights into the long-term impact of these short-term findings."

About the Study

Opticept is a two-year open-label, prospective, randomized, multicenter study involving 720 single-organ renal allograft recipients administered either concentration-controlled CellCept and a reduced level of CNI, a concentration-controlled CellCept and the standard level of CNI, or a fixed-dose of CellCept and the standard level CNI.

Antibody induction and/or corticosteroids were administered according to center practice. Primary endpoints were the proportion of patients with treatment failure
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SOURCE Roche
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