NCT03054545Unknown不适用
Evaluation of Clinical Efficacy and Immunologic Response After Iguratimod Therapy in Refractory Lupus Nephritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Renal remission rate
研究概览
简要总结
This study is to evaluate the efficacy and safety of a novel chemical synthetic agent iguratimod as treatment of refractory lupus nephritis. All subjects should have at least one failed immunosuppressive treatment and suffer active nephritis at the screening stage. The study period is 52 week. All the subject will receive therapy of iguratimod combined with steroids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active lupus nephritis:
- •Fulfill ACR classification criteria (2009) for SLE Proteinuria ≥1g/24h at screening stage experience at least one failed therapy within one year before screening, including but not limit to cyclophosphamide, methotrexate, azathioprine, mycophenolate mofetil, cyclosporin, tacrolimus and leflunomide. The regime can be monotherapy or combination. Any regime should be at least applied for six months.
- •Body weight ≥40kg
- •SLE-2K score ≥8
- •Agreement of contraception
- •Informed consent obtained
排除标准
- •Active severe SLE-driven renal disease or unstable renal disease at screening
- •Active severe or unstable neuropsychiatric SLE
- •Clinically significant active infection including ongoing and chronic infections
- •History of human immunodeficiency virus (HIV)
- •Confirmed Positive tests for hepatitis B or positive test for hepatitis C
- •Active tuberculosis
- •Live or attenuated vaccine within 4 weeks prior to screening
- •Subjects with significant hematologic abnormalities
- •Abnormal liver function test at screening (ALT, AST or total bilirubin over 2 fold of upper normal level
- •History of peptic ulcer or GI bleeding; treatment with warfarin or other anticoagulants within last 14 days
研究组 & 干预措施
Iguratimod treating group
Experimental
Iguratimod 25mg twice a day, oral administrated.
干预措施: Iguratimod (Drug)
结局指标
主要结局
Renal remission rate
时间窗: Week 52
次要结局
- Renal remission rate(Week 24)
- Systemic Lupus Erythematosus Disease Activity Index inSafety of Estrogens in Lupus Erythematosus National Assessment (SELENA-SLEDAI)(Week 52)
- Quality of life(Week 52)
- Renal flare rate(Week 52)
- Number of participants with treatment-related adverse events(Week 52)
- British Isles Lupus Activity Group (BILAG) score(Week 52)
- PGA(Week 52)
研究者
研究点 (1)
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