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

ion, graft loss, death, and the percent change in measured GFR.

After 12 months of follow-up, investigators found acute rejection in 6.1% of patients in the CellCept and sirolimus group, compared to 7.3% of patients in the CellCept and CNI group. Graft loss was experienced by 2.0% of patients in the CellCept and sirolimus group, compared to 3.6% of patients in the CellCept and CNI group.

None of the patients in the CellCept and sirolimus group died, while one patient death was remotely related to the CellCept and CNI group. Patients in the CellCept and sirolimus group had a median 18.5% increase from baseline in GFR, compared to a median 4.4% decrease in the CellCept and CNI group. Safety outcomes were similar in both groups.

Optimizing use of immunosuppressants for achieving long-term success is the primary focus of these clinical trials. Kidney STN, liver STN and OptiCept are all studying CellCept with the goal of reducing CNI associated nephrotoxicity therapy to prolong graft and patient survival. Final results of this study, which will be available later this year, will provide more definitive conclusions about the long-term effect of these regimens on renal function.

About CellCept

CellCept is an immunosuppressant or anti-rejection drug approved for use in combination with other immunosuppressive drugs (cyclosporine and corticosteroids) for the prevention of rejection in patients receiving kidney, heart and liver transplants.

There are no adequate and well-controlled studies in pregnant women. As CellCept has been shown to have teratogenic effects in animals at subclinical doses on a body surface area basis, it may cause fetal harm when administered to a pregnant woman. CellCept should not be used in pregnant women unless the potential benefit justifies the potential risk to the fetus. Women of childbearing potential should have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within one
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