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Final Results of the CellCept(R) Spare the Nephron (STN) Study Show Maintenance Therapy is Associated with Improved Renal Function
Date:6/1/2008

TORONTO, June 1 /PRNewswire/ -- The final results of the Spare the Nephron (STN) study, a multicenter trial investigating a novel kidney-sparing treatment protocol using CellCept(R) (mycophenolate mofetil), showed the CellCept-based regimen in combination with sirolimus (SRL) is associated with improved renal function when compared with the CellCept-based regimen in combination with calcineurin inhibitors (CNI).

Furthermore, the study showed this improvement without increasing the risk of acute rejection, and was tolerated in almost 80 percent of patients. The results were presented today at the American Transplant Congress (ATC) in Toronto.

The STN Trial in kidney transplant recipients examines ways to prevent rejection without damaging kidneys. 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. "This study provides strong evidence for the benefits of a CNI-free, CellCept-based regimen," said Thomas Pearson, M.D., lead investigator, Livingston Professor of Surgery, Department of Surgery, Emory University School of Medicine, Atlanta, GA.

The STN trials were conducted at more than 35 transplant centers in the United States and Canada.

"The goal of this study was to optimize the use of immunosuppressants for achieving long-term success," added Dr. Pearson. "The STN Kidney studied the combination of CellCept and SRL with the goal of reducing CNI associated nephrotoxicity therapy to prolong graft and patient survival."

About the Study

This open-label, prospective, multicenter study, randomized 305 patients (maintained on MMF and a CNI) for 30-180 days post-transplant to receive either MMF (1-1.5 g BID) plus SRL (2-10 mg followed by at least 2 mg/day; trough 5-10 ng/mL) and discontinue the CNI (MMF/SRL) or to continue their current regimen (MMF/CNI). Antibody induction and/or corti
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SOURCE Roche
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