A randomized, multicenter, 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 flare - Mylupus

• Conditions: Systemic Lupus Nephritis; MedDRA version: 8.1Level: LLTClassification code 10025140Term: Lupus nephritis

• Registration Number: EUCTR2006-002107-13-FR
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-27
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

- male or female with SLE (at least classification 4 of ACR)
- Aged > or = 18 years
- Proliferative lupus nephritis cassified as ISN/RPS class III or IV
- Renal biopsy must be performed during the last 18 months 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>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

- patients with serum creatinine on repeated testing >3mg/dl or calculated creatinine clearance of < 20 ml/mn
- Patients having received an iv corticosteroid bolus during the last 3 months
- Patients having received oral or iv cyclophosphamide during the last 3 months
- Patients having received MMF within the preceding 6 months
- Use of any antibody therapy within the past 6 months
- Pregnant or nursing women
- women of child-bearing potential who are planning to become pregnant
- Use of other investigational drugs within 1 month of enrollment (except for antibodies : within 6 months 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