Systemic Lupus Nephritis
Conditions
Interventions
Trade Name: Myfortic
Pharmaceutical Form: Gastro-resistant tablet
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - male or female with SLE (at least classification 4 of ACR) - Aged >/ 18years - Proliferative lupus nephritis cassified as ISN/RPS class III or IV - Renal biopsy must be performed during the last 12 mont preceding the lupus nephritis flare -Proteinuria defined as >0.5gm urine protein per gram urine creatinine - Clinical activity defined by one or more of the following changes in renal function: serum creatinine>1mg/dl / microscopic haematuria defined as > 5 rbcs per high power field / presence of cellular casts Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - patients with serum creatinine on repeated testing >3mg/dl or calculated creatinine clearance of < 20ml/mn - Patients having received an iv corticosteroid bolus during the last 3m - Patients having received MMF within the preceding 6m -Use of monoclonal antibody therapy within the past 30 days - Pregnant or nursing women - women of child-bearing potential who are planning to become pregnant - Use of other investigational drugs within im of enrollment - History of hypersensitivity to study drugs - History of malignancy within the past 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to explore in non-inferior efficacy of Myfortic administered at a dose of 2160mg/day in combination with reduced corticosteroid regimen compared to the combination with a standard corticosteroid regimen where efficacy measure is defined as the proportion of patients in complete remission after 24 weeks of treatment;Secondary Objective: To assess/evaluate the following main (not complete list) secondary objectives: - Proportion of patients in complete remission at 12 weeks and partial remission of lupus flares at 12 weeks and at 24 weeks. - The corticosteroid use as cumulative dose until 12 and 24 weeks of treatment, also doses at baseline, 12 and 24 weeks - Overall disease activity using BILAG and SLEDAI activity indices at week 24 - Proportion of patients with mild SLE flare at 12 and 24 weeks and with moderate/severe SLE flare at 12 and 24 weeks - Organ damage, utilising the SLICC/ACR Damage Index at 24 weeks - Renal function (serum creatinine, creatinine clearance, GFR and the urine protein/ creatinine ratio - Patients with no therapeutic response at 12 and 24 weeks - Patients with treatment failure at 12 and 24 weeks - Proportion of patientswith AEs, SAEs and infections during the course of the study ;Primary end point(s): The primary objective of the study is to explore the non-inferior efficacy of Myfortic® administered at a dose of 2160 mg/day in combination with reduced CS regimen compared to the combination with standard CS regimen where efficacy measure is defined as the proportion of patients in complete remission after 24 weeks of treatment. | — |
Countries
France, Germany, Greece, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed