NCT01172002Unknown不适用
A Randomized Multicenter Trial Comparing Leflunomide and Azathioprine as Remission-Maintaining Treatment for Proliferative Lupus Glomerulonephritis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- lupus nephritis flare
研究概览
简要总结
Leflunomide versus Azathioprine for Maintenance Therapy of Lupus Nephritis
详细描述
Proliferative glomerulonephritis is a common and severe manifestation of systemic lupus erythematosus (SLE) that usually requires intensive therapy with high doses of glucocorticosteroids and cytotoxic drugs, such as intravenous (IV) cyclophosphamide (CYC). The objective of this Trial is to compare leflunomide (LEF) and azathioprine (AZA), in terms of efficacy and toxicity, as remission-maintaining treatment of proliferative lupus glomerulonephritis, after a remission-inducing therapy with a short-course IV CYC regimen. The hypothesis of this trial is that LEF is non-inferior to AZA.
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
- •Aged 18 to 65 years
- •Biopsy-proven proliferative lupus nephritis
- •Disease activity, SLEDAI score ≥ 8 points
- •Persistent proteinuria (≥ 1g/24h), with or without microscopic hematuria;
- •Signed informed consent
排除标准
- •Allergy to the LEF, CTX, AZA
- •Recent treatment with high-dose glucocorticoids
- •Weight <45kg
- •Recent treatment with immunosuppressive drugs
- •CNS( Central Nerve System) Lupus patients
- •Hepatic failure patients
- •Severely abnormal renal function or end-stage renal failure
- •More exclusion criteria in the protocol
研究组 & 干预措施
leflunomide group
Experimental
干预措施: Leflunomide (Drug)
Azathioprine group
Active Comparator
干预措施: Azathioprine (Drug)
结局指标
主要结局
lupus nephritis flare
时间窗: two years
次要结局
- 24-hour proteinuria over time(two years)
- Serum albumin over time(two years)
- Number of extra renal flare(two years)
- Cumulated glucocorticoid intake(two years)
研究者
研究点 (1)
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