A Study of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis.

• Rate of response in induction phase [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
• Time to complete remission [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
• Renal function, discontinuations, time to treatment failure, AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

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.

• Drug: mycophenolate mofetil [CellCept]
  1g po bid for 24 weeks, followed by 0.75g po bid for 24 weeks.
• Drug: Corticosteroids
  As prescribed for 48 weeks
• Drug: Azathioprine
  2mg/kg /day po during weeks 24-48
• Drug: Cyclophosphamide
  0.5-1.0g/m2 monthly for 24 weeks

• Experimental: 1
  Interventions:

  • Drug: mycophenolate mofetil [CellCept]
  • Drug: Corticosteroids
• Active Comparator: 2
  Interventions:

  • Drug: Corticosteroids
  • Drug: Azathioprine
  • Drug: Cyclophosphamide

Inclusion Criteria:

• adult patients, 18-75 years of age;
• systemic lupus erythematosus;
• histological diagnosis of lupus nephritis.

Exclusion Criteria:

• not in need of immunosuppressive treatment (in addition to corticosteroids);
• continuous dialysis starting >2 weeks before randomization, with an anticipated duration of >8 weeks;
• previous or planned kidney transplant.