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

ovartis Pharma Services AG0 个研究点目标入组 98 人开始时间: 2006年10月27日最近更新: 2015年8月4日

研究概览

暂无简介。

•- 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

•- 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

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