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 - ND

• Conditions: Systemic lupus erythematosis; MedDRA version: 9.1Level: LLTClassification code 10042945Term: Systemic lupus erythematosus

• Registration Number: EUCTR2006-002107-13-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-09
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Male or female patients with SLE at least 4 classification criteria of the ACR , 2. Aged 8805;18 years, 3. Proliferative lupus nephritis classified as ISN/RPS class III or IV, 4. Renal biopsy must be performed within the last 12-month preceding the lupus nephritis flare, 5. Proteinuria defined as 0.5gram urine protein per gram urine creatinine 6. Clinical activity defined by one or more of the following changes in renal function - Serum creatinine 1.0 mg/dl 88.4 mol/l , - Microscopic hematuria defined as 5 red cells 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

1. Patients with serum creatinine on repeated testing 3.0 mg/dl 265.2 mol/l or calculated creatinine clearance 20ml/mn, 2. Patients having received an IV CS bolus during the last 3 months, 3. Patients having received MMF within the 6 preceding months , 4. Use of monoclonal antibodies within 30 days, 5. Pregnant or nursing lactating women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test 5 mIU/ml , . 6. Women of child-bearing potential WOCBP , 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, 7. Use of other investigational drugs within 1 month of enrollment, 8. History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures, 9. 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified