Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Intervention: Mycophenolate sodium; Prednisone; Methylprednisolone
Intervention description: Mycophenolate sodium as administered orally for 2 weeks at 1440mg daily and then increased to 2160mg daily for 22 weeks.; Oral prednisone or prednisone equivalent was started on Day 4 and subsequently tapered every 2 weeks according to the patient's weight.; All patients received bolus therapy with 0.5 g of intravenous Methylprednisolone per day for 3 consecutive days.
Intervention MeSH terms: Mycophenolic Acid; Prednisone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lupus Nephritis; enteric-coated mycophenolate sodium; EC-MPS; Myfortic

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)
    

Eligibility criteria:

        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.