A Randomized Controlled Multi-center Trial of Mycophenolate Mofetil for the Patient With High Risk Membranous Nephropathy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 9
- 主要终点
- Percentage of Complete Remission
研究概览
简要总结
Cyclosporin decreases proteinuria and improve renal function in patients with idiopathic membranous nephropathy, but has a risk of side effects such as nephrotoxicity. The investigators plan to the study to evaluate whether mycophenolate mofetil (MMF) could be a reasonable alternative with fewer side effect.
详细描述
Idiopathic membranous nephropathy is most common cause of glomerulonephritis in adults. Persistent high grade proteinuria or progressively decrease of renal function is a risk factor for end stage renal disease in idiopathic membranous nephropathy. It has been reported that cyclosporin in patients with idiopathic membranous nephropathy decreases proteinuria and improve renal function. Mycophenolate mofetil is a recently developed immunosuppressive agent with fewer side effect than cyclosporin. In this study patients with high risk group of progressive idiopathic membranous nephropathy will be treated with mycophenolate mofetil and low dose prednisone. The outcome will be compared to controls treated with cyclosporin and low dose prednisone.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with idiopathic membranous nephropathy
- •The duration of disease is less than twelve months
- •Patients with persistent proteinuria more than 8 grams per day
- •Patients who provided informed consent
- •The cases that satisfy more than three of following items even if proteinuria is less than 8 grams per day:
- •eGFR < 60 ml/min/1.73m2
- •Hypertension (BP above 140/90mmHg or BP above 120/80 in patients taking anti-hypertensive agents)
- •24 hours urine protein or spot urine protein/creatinine ratio > 5.0 g/day
- •Serum albumin (g/dL) < 3.0
- •Selectivity index > 0.2
排除标准
- •Severe digestive organ disease
- •Allergy history to clinical trial medication and acute or chronic allergy for 4 weeks recently.
- •Clinical history of treatment with other immunosuppressive medication
- •Probability of pregnancy, breast feeding woman
- •Uncontrolled hypertension (more than 160/100mmHg)
- •Uncontrolled systemic disease
- •Drug addiction or alcoholics within 6 months
- •eGFR is less than 30ml/min at screening
- •Abnormal liver function test (more than 3 times above compared with normal value)
- •Absolute neutrophil count <1,500/mm3 or leukocyte <2,500/mm3 or platelets <100,000/mm3
- •Secondary membranous nephropathy
- •Expected life expectancy is less than 1 year
研究组 & 干预措施
Mycophenolate mofetil, low dose steroid
干预措施: Mycophenolate mofetil, low dose steroid (Drug)
Cyclosporin, low dose steroid
干预措施: Cyclosporin, low dose steroid (Drug)
结局指标
主要结局
Percentage of Complete Remission
时间窗: at 48 week after treatment
Complete remission: Reduction in proteinuria to 200 mg per day with stable serum albumin with more than 3.5 g/dL
Percentage of Partial Remission
时间窗: at 48 week after treatment
Partial remission: Reduction in proteinuria to greater than 50 percent of initial values or absolute values of proteinuria between 200 mg and 3.5 g per day
次要结局
- Estimated Glomerular Filtration Rate (eGFR)(at 48 week after treatment)
- Relapse(For 48 weeks after treatment)
- Proteinuria(at 48 week after treatment)
- Side Effects(For 48 weeks after treatment)
研究者
Sun-Hee Park
Professor
Kyungpook National University Hospital