drugset / Trial / NCT00423098
Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare
RandomizedParallel-groupOpen-labelTreatment
Summary
The study will investigate the efficacy and safety of enteric-coated mycophenolate sodium in combination with two different corticosteroid (CS) regimes for the induction of remission of a lupus nephritis flare. Patients will be randomly allocated to standard CS regimen (group I) or to a reduced dose CS regimen (group II)
Timeline
- Start
- 2007-02
- Primary completion
- 2009-11
- Completion
- 2009-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mycophenolate Sodium | Unknown | 2160 mg | Oral |
| Subject | Prednisone | Other / unclassified | 0.5 mg/kg | Oral |
| Subject | Prednisone | Other / unclassified | 1 mg/kg | Oral |
| Background | Methylprednisolone | Other / unclassified | 0.5 g | Intravenous |