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Early Results of the CellCept Spare the Nephron Study Examine,Kidney Function

SAN FRANCISCO, May 07, 2007 /PRNewswire/ -- Interim results from a multicenter trial investigating a novel kidney-sparing treatment protocol using CellCept(R) (mycophenolate mofetil) were presented at the American Transplant Congress. This and other Spare the Nephron (STN) trials in kidney and liver transplant recipients examine ways to prevent rejection without damaging kidneys.

As transplant patients are living longer, doctors are finding that older therapies such as steroids and calcineurin inhibitors (CNIs) can cause impairment of kidney function and damage to the blood vessels and filtering capacity of the kidneys.(1)(2) The STN trials are being conducted at more than 35 transplant centers in the United States and Canada and use CellCept and other immunosuppressants in combinations that reduce or eliminate the use of steroids and CNIs.

"Our goal for the Spare the Nephron trial in kidney transplant recipients is to determine the safest and most effective immunosuppressive therapy regimen that avoids the nephrotoxic effects of CNIs while preventing rejection," said Matthew Weir, M.D., professor and director of the division of nephrology at the University of Maryland School of Medicine. "The preliminary study results are very encouraging."

Dr. Weir reported that first-year results in kidney transplant recipients demonstrated that patients on CellCept and sirolimus maintenance therapy showed improvements in glomerular filtration rate (GFR) of their kidneys without increasing rejection rates.

A total of 208 of 305 kidney transplant patients completed 12 months of follow-up in this open-label, prospective, randomized, multicenter study. Patients initially treated with CellCept and a CNI were randomized to receive CellCept and sirolimus or to continue their current treatment regimen of CellCept and a CNI. Efficacy endpoints included the proportions of patients experiencing acute reject
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