EUCTR2006-002107-13-GR进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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
排除标准
- •- 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
研究者
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