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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

(BPAR, graft loss, and death) and mean percent change in calculated glomerular filtration rate (GFR; Nankivell equation) at 12 months. Safety endpoints were incidences of adverse events and serious adverse events. Non-inferiority for treatment failure was tested. Baseline characteristics did not differ among treatment groups with living donors accounting for approximately 50 percent of grafts. Eighty-two percent received tacrolimus (Tac) and 18 percent cyclosporine (CyA). CNI doses and levels were significantly lower in the reduced level of CNI. CellCept doses were greater in CyA-treated subjects in all groups.

Study Results

After 12 months, treatment failure resulted in 20.6 percent (50/243) in the concentration-controlled CellCept and a reduced level of CNI group, compared to 28.7 percent (68/237) in the concentration-controlled CellCept and the standard level of CNI group, and 26.7 percent (64/240) in the fixed-dose of CellCept and the standard level CNI group.

Five patients (2.1 percent) in the concentration-controlled CellCept and a reduced level of CNI group died; two patients (0.8 percent) died in the concentration-controlled CellCept and the standard level of CNI group; and five patients (2.1 percent) died in the fixed-dose of CellCept and the standard level CNI group.

Groups Patients Graft Loss BPAR Lost to f/u

MMFcc/CNIrl 243 5 (2.1%) 15 (6.2%) 25 (10.3%)

MMFcc/CNIsl 237 4 (1.7%) 23 (9.7%) 23 (9.6%)

MMFfd/CNIrl 240 4 (1.7%) 23 (9.6%) 32 (13.3%)

Note: events are mutually exclusive because only first event counted/patient

Serum creatinine tended to lower at 12 months in the Tac versus CyA treated patients and in the concentration-controlled CellCept and reduced level of CNI group (p=0.08). The stability of renal function over time was greatest in this group as well. Despite higher CellCept doses in the conc
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SOURCE Roche
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