A Study of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis.
Status:
Terminated
Trial end date:
2008-04-01
Target enrollment:
Participant gender:
Summary
This 2 arm study will compare the efficacy and safety of CellCept plus corticosteroids,
versus cyclophosphamide plus corticosteroids in the induction phase followed by azathioprine
in the maintenance phase, in maintaining remission and renal function in patients with lupus
nephritis. Patients will be randomized to receive CellCept 1g bid po plus corticosteroids for
24 weeks, followed by CellCept 0.75g bid po plus corticosteroids for the following 24 weeks,
or cyclophosphamide 0.5-1.0g/m2 monthly plus corticosteroids for 24 weeks, followed by
azathioprine 2mg/kg/day po plus corticosteroids for the following 24 weeks. Response rate
will be assessed at the end of the induction phase, and at the end of study. The anticipated
time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.