The Effect of Iguratimod on Active Lupus Nephritis, the IGeLU Study: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- renal remission rate
研究概览
简要总结
This study is a 52-week, randomized, open, active-controlled trial of patients with active diffused lupus nephritis, to assess the efficacy and safety of a novel chemical synthetic agent iguratimod. The subjects will randomly receive iguratimod or cyclophosphamide followed with azathioprine, both combined with steroids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Nephritis of class III, IV, V, III+IV or IV+V, confirmed by renal pathology within 90 days prior to screening
- •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 receiving cyclophosphamide, azathioprine, tacrolimus , mycophenolate moetil or rituximab treatment with 90 days prior to screening
- •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
Patients will receive iguratimod over the whole follow-up, combined with steroids, as well as auxiliary treatment (such as vitamin D, gastrointestinal agents, blood pressure medications, if any)
干预措施: Iguratimod (Drug)
Iguratimod
Patients will receive iguratimod over the whole follow-up, combined with steroids, as well as auxiliary treatment (such as vitamin D, gastrointestinal agents, blood pressure medications, if any)
干预措施: Steroids (Drug)
Cyc+AZA
Patients will receive cyclophosphamide in the first half of study (usually to 24 weeks), followed with azathioprine till the end of follow-up. Patients will also receive steroids as combinational therapy, as well as auxiliary treatment (such as vitamin D, gastrointestinal agents, blood pressure medications, if any)
干预措施: Cyclophosphamide (Drug)
Cyc+AZA
Patients will receive cyclophosphamide in the first half of study (usually to 24 weeks), followed with azathioprine till the end of follow-up. Patients will also receive steroids as combinational therapy, as well as auxiliary treatment (such as vitamin D, gastrointestinal agents, blood pressure medications, if any)
干预措施: Azathioprine (Drug)
Cyc+AZA
Patients will receive cyclophosphamide in the first half of study (usually to 24 weeks), followed with azathioprine till the end of follow-up. Patients will also receive steroids as combinational therapy, as well as auxiliary treatment (such as vitamin D, gastrointestinal agents, blood pressure medications, if any)
干预措施: Steroids (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)
- BILAG score(Week 52)
- PGA(Week)
- Renal flare rate(Week 52)
- Number of participants with treatment-related adverse events(Week 52)
- SLEDAI-2K score(Week 52)