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 (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.
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.
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 concentration-controlled CellCept and reduced level of CNI group (p<0.001) at most time points, significantly fewer CellCept withdrawals occurred versus the other two groups.
CellCept is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. CellCept should be used concomitantly with cyclosporine and corticosteroids.
Important Safety Information:
Immunosuppression may lead to increased susceptibility to infection and possible development of lymphoma. Only physicians experienced in immunosuppressive therapy and management of renal, cardiac or hepatic transplant patients should use CellCept. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.
Female users of childbearing potential must use contraception. Physicians should inform female patients that CellCept use during pregnancy is associated with increased rates of pregnancy loss and congenital malformations.
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