drugset / Trial / NCT02081183
A Study to Evaluate Efficacy of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will compare the efficacy of CellCept \[0.5-2 grams per day (g/day) orally (p.o.)\] and cyclophosphamide \[0.5-1 grams per square meter (g/m2) quarterly\] as maintenance treatment for patients with lupus nephritis. All patients will receive induction treatment with cyclophosphamide (0.5-1g/m2 monthly) for 6 months, and will then be randomized to the maintenance phase of the study for a further 6 months, followed by 6 months of treatment-free follow-up. The anticipated time on study treatment is 12 months.
Timeline
- Start
- 2006-03
- Primary completion
- 2008-12
- Completion
- 2008-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | 0.5 g | Intravenous |
| Comparator | Cyclophosphamide | Other / unclassified | 1 g | Intravenous |
| Subject | Mycophenolate Mofetil | Small molecule | 2 g | Oral |
| Background | Prednisone | Other / unclassified | 10 mg | Oral |