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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborator: Aspreva Pharmaceuticals
• Treatments: Azathioprine; Cyclophosphamide; Mycophenolate mofetil; Mycophenolic Acid

Criteria

Inclusion Criteria:

• male or female patients, 12-75 years of age;

• diagnosis of systemic lupus erythematosus;

• kidney biopsy within 6 months of study, with histological diagnosis of lupus nephritis;

• laboratory evidence of active nephritis.

Exclusion Criteria:

• continuous dialysis starting >2 weeks before randomization into induction phase, and/or with an anticipated duration of >8 weeks;

• previous or planned kidney transplant;

• other clinically significant active medical conditions.