A Study of Mycophenolate Mofetil (CellCept) in Management of Patients With Lupus Nephritis.
Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
Participant gender:
Summary
This 2 arm study assessed the efficacy of Mycophenolate Mofetil (MMF; CellCept) compared to
cyclophosphamide in inducing a response in patients with lupus nephritis, and the long term
efficacy of MMF compared to azathioprine in maintaining remission and renal function.
Patients were randomized to receive either MMF (1.5 g twice daily [bid]) or cyclophosphamide
(0.5-1.0 g/m^2 in monthly pulses) in the induction phase. Those patients meeting criteria for
response were re-randomized for entry into the maintenance phase, to receive either MMF (1 g
bid) or azathioprine (2 mg/kg/day).