The Efficacy of Prednisone Alone and Combination Therapy With Methylprednisolone and Cyclophosphamide in the Treatment of Membranous Nephropathy in Stage I.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- nephrotic syndrome remission ( including complete remission and partial remission)
研究概览
简要总结
Multi-center, prospective, randomized, controlled study to verify the efficacy of prednisone alone and combination therapy with methylprednisolone and cyclophosphamide in the treatment of stage I membranous nephropathy.
详细描述
Idiopathic membranous nephropathy (IMN) is one of the most common cause of adult nephrotic syndrome. Prednisolone and methylprednisolone are essential drugs for IMN. However, there are no recommendations for the treatment of IMN in China. KDIGO guidelines recommend combination therapy with methylprednisolone and cyclophosphamide as first-line therapy of IMN, but there is a large side effect of cyclophosphamide.There were retrospective study showed that the use of glucocorticoid hormones (including prednisone and methylprednisolone) alone may be effective in patients with membranous nephropathy in Asia, but there is no high quality evidence of evidence-based medicine.The study is a randomized prospective controlled multi-centered trial,to compare the efficacy of prednisone alone and combination therapy with methylprednisolone and cyclophosphamide in the treatment of membranous nephropathy in stage I.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The pathological examination of renal biopsy was consistent with the early idiopathic membranous nephropathy
- •Meeting one of the following three condition：
- •Urine protein quantitation >4g/d,or 50% higher than baseline,RASS blocker treat for 6 months without trend of decrease ②Serious or disabling complications related to nephrotic syndrome ③In the 6-12 months after diagnosis of idiopathic membranous nephropathy, serum creatinine increased by more than 30%, while eGFR eGFR≥25ml/min/1.73m2.And excludeing other causes of renal dysfunction
排除标准
- •Secondary membranous nephropathy
- •Serious complications
- •Considering the effect of cyclophosphamide on the of function of sex gland，all patients with childbearing age or fertility requirement cannot participate in this study
研究组 & 干预措施
Group prednisone
Prednisone was taken 1mg/kg/d(maximum 60mg/d)for 8 weeks to start.Then decreased 5mg every 2 weeks; When reduced to 40mg,reduced 5mg every 4 weeks. When reduced to 20mg, reduced 2.5mg every 8 weeks until the end.
干预措施: Prednisone (Drug)
Group MP and CTX
The first month,Methylprednisolone(MP) was injected for 3 days(weight >60kg,500mg/d;<60 kg,300mg/d),and 0.4mg/kg/d for 27 day.The second month,Cyclophosphamide(CTX) orally was 100mg/d for 1 month.And this regimen is repeated for six months.
干预措施: MP and CTX (Drug)
结局指标
主要结局
nephrotic syndrome remission ( including complete remission and partial remission)
时间窗: 12 months
nephrotic syndrome remission ( including complete remission and partial remission)
次要结局
- blood albumin≥30g/L(12 months)
研究者
Wenhu Liu
Professor
Beijing Friendship Hospital