Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare

A Randomized, Multicenter, Open-label, 6-month Study to Explore the Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare

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)

Inclusion criteria

• Male or female patients with systemic lupus erythematosus (SLE)(at least 4 classification criteria)
• Aged ≥18 years,
• Proliferative lupus nephritis classified as ISN/RPS class III or IV
• Renal biopsy within the last 24-month preceding the study entry
• Proteinuria defined as >0.5 gram urine protein per gram urine creatinine at screening and baseline
• Clinical activity defined by one or more of the following changes in renal function: Serum creatinine >1.0 mg/dl (88.4 μmol/l)
• Microscopic hematuria defined as >5 red cells per high power field
• Presence of cellular casts

Exclusion criteria

• Patients with calculated creatinine clearance <30 ml/min (using the Cockcroft-Gault formula)
• Patients having received an intravenous (i.v.) corticosteroid bolus during the last 3 months,
• Patients having received oral or i.v. cyclophosphamide during the last 3 month
• Patients having received mycophenolate mofetil (MMF) within the preceding 3 months
• Use of any antibody therapy within the past 6 months
• Pregnant or nursing (lactating) women or women of child-bearing potential who are planning to become pregnant, or are not willing to use effective means of contraception throughout the study and during one month after the end of the study.
• Use of other investigational drugs within 1 month of enrollment (except for antibodies: within 6 months of enrollment
• History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures,
• History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.

Other protocol-defined inclusion/exclusion criteria may apply.