Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Change in serum albumin
研究概览
简要总结
This study is designed to compare the safety and efficacy of Mycocep Capsules (Mycophenolate Mofetil) and a marketed Azathioprine formulation, Imuran Azathioprine Tablets, in the maintenance therapy of lupus nephritis.
详细描述
This study is designed to compare the two different doses of Mycocep Capsules (1.0g/day & 1.5g/day) and Imuran Azathioprine Tablets (2mg/kg/day), all in combination with low-dose prednisolone (≤10mg/day) as maintenance treatment for lupus nephritis.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of lupus nephritis.
- •Currently receiving maintenance therapy with Azathioprine, Mycophenolate Mofetil, Mycophenolate Sodium, or Cyclosporine for lupus nephritis for at least 3 months prior to randomization.
- •Stable use of low dose (≤10mg/day) oral prednisolone for lupus nephritis for at least 3 months prior to randomization.
排除标准
- •Untreated, not in need of immunosuppressive treatment (in addition to corticosteroids), currently receiving induction therapy, or not responding to Azathioprine, Mycophenolate Mofetil or Mycophenolate Sodium as induction or maintenance therapy for lupus nephritis.
- •Currently receiving or anticipated to receive cyclophosphamide or IV pulse of corticosteroids.
- •Currently receiving continuous dialysis starting more than 2 weeks before randomization, and/or with an anticipated duration of more than 8 weeks.
- •Previous kidney transplant or planned transplant.
- •Presence of life threatening complications such as cerebral lupus or severe infection.
- •Presence of liver dysfunction.
- •Presence of COPD or asthma requiring oral steroids.
- •Presence of bone marrow insufficiency or pure red cell aplasia unrelated to active systemic lupus erythematosus.
- •Presence of persistent hematuria or pyuria for causes other than lupus nephritis.
研究组 & 干预措施
MMF 500mg
Mycophenolate mofetil 500mg, PO BID
干预措施: Mycophenolate mofetil (Drug)
MMF 500mg
Mycophenolate mofetil 500mg, PO BID
干预措施: Prednisolone (Drug)
MMF 750mg
Mycophenolate mofetil 750mg, PO BID
干预措施: Mycophenolate mofetil (Drug)
MMF 750mg
Mycophenolate mofetil 750mg, PO BID
干预措施: Prednisolone (Drug)
AZA
Azathioprine 1mg/kg, PO BID
干预措施: Azathioprine (Drug)
AZA
Azathioprine 1mg/kg, PO BID
干预措施: Prednisolone (Drug)
结局指标
主要结局
Change in serum albumin
时间窗: 24 weeks treatment
Change in serum creatinine
时间窗: 24 weeks treatment
Change in spot urine protein/creatinine ratio
时间窗: 24 weeks treatment
次要结局
- Change in spot urine protein/creatinine ratio(12 weeks treatment)
- Change in cholesterol(24 weeks treatment)
- Change in complete blood count/differential count (CBC/DC)(24 weeks treatment)
- Change in serum albumin(12 weeks treatment)
- Change in serum creatinine(12 weeks treatment)
- Change in triglyceride(24 weeks treatment)
- Change in number of subjects with doubling of serum creatinine(24 weeks treatment)
- Change in the average daily dose of oral prednisolone(24 weeks treatment)