A Randomized Multicenter Trial Comparing Mycophenolate Mofetil and Azathioprine as Remission-maintaining Treatment for Proliferative Lupus Glomerulonephritis. The MAINTAIN Nephritis Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Time to renal flare
研究概览
简要总结
The purpose of the study is to determine whether mycophenolate mofetil is superior to azathioprine to prevent flares 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 the MAINTAIN Nephritis Trial is to compare mycophenolate mofetil (MMF) 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 addressed by the MAINTAIN Nephritis Trial is that MMF is superior 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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SLE aged ≥ 14 years
- •Proteinuria ≥ 500 mg/day
- •Biopsy-proven proliferative lupus nephritis
排除标准
- •Recent treatment with high-dose glucocorticoids
- •Recent treatment with immunosuppressive drugs
- •More exclusion criteria in the protocol
研究组 & 干预措施
1
Mycophenolate mofetil (target dose 2g/day)
干预措施: Mycophenolate mofetil (Drug)
2
Azathioprine (target dose 2mg/kg/day)
干预措施: Azathioprine (Drug)
结局指标
主要结局
Time to renal flare
时间窗: 5 years
次要结局
- Number of withdrawals due to toxicity(5 years and 10 years)
- Number of treatment failures(5 years and 10 years)
- Cumulated glucocorticoid intake(5 years and 10 years)
- 24-hour proteinuria over time(5 years and 10 years)
- Serum creatinine titers(5 years and 10 years)
- Time to renal flare(10 years)
研究者
Frédéric A. Houssiau, MD, PhD
Professeur Ordinaire, Chef de Service Clinique
Université Catholique de Louvain