A randomized, multicentre, open-label, 6-month study to explore the efficacy and safety of enteric coated mycophenolate sodium (Myfortic) in combination with two corticosteroid regimens for the treatment of lupus nephritis - Mylupus
- Conditions
- Systemic Lupus Nephritis
- Registration Number
- EUCTR2006-002107-13-HU
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method