NCT00135967已完成2 期
Treatment of Patients With Membranous Nephropathy and Renal Insufficiency With Mycophenolate Mofetil and Prednisone: a Pilot Study
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- renal function (serum creatinine)
研究概览
简要总结
Patients with idiopathic membranous nephropathy and renal insufficiency are at risk for end-stage renal disease (ESRD). Treatment with cyclophosphamide is currently used as a treatment modality. Mycophenolate mofetil is a new immunosuppressive agent with fewer side effects.
In this pilot study patients with membranous nephropathy and renal failure will be treated with mycophenolate mofetil and prednisone. The outcome will be compared with historical controls treated with a similar regimen containing cyclophosphamide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Membranous nephropathy
- •Serum creatinine (Screat)> 1,5 mg/dl or ECC < 70 ml/min or increase Screat > 50%
- •Proteinuria > 2 g/day
排除标准
- •Systemic diseases
- •Pregnancy wish
- •Active infection
- •Liver dysfunction
- •Abnormal hematology lab
- •Unstable angina
- •Nonsteroidal anti-inflammatory agents (NSAIDs)
结局指标
主要结局
renal function (serum creatinine)
proteinuria
次要结局
- side effects
- relapse rate
研究者
研究点 (2)
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