The Effects of Mycophenolate Mofetil on Renal Outcomes in Patients With Advanced IgA Nephropathy: a Randomized Open-label Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 238
- 试验地点
- 3
- 主要终点
- To evaluate the effects of mycophenolate mofetil on a composite renal outcomes in subjects with advanced IgA nephropathy
研究概览
简要总结
The study is to evaluate the effect of Mycophenolate Mofetil compared with losartan alone on time to doubling of serum creatinine or the onset of end stage renal disease in patients with advanced IgA nephropathy who are treated with the maximal tolerated daily dose of losartan.The study will also assess the effects of MMF compared with losartan alone on the changes of urine albumin excretion and the changes in estimated glomerular filtration rate.
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
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven primary IgA nephropathy with urinary proteinuria excretion over 1g/24 hour,subjects must meet 2 of the following criteria:
- •global glomerular sclerosis plus focal segmental glomerular sclerosis ratio ≥50%
- •eGFR 30 to 60 ml/min
- •Hypertension (blood pressure over 140/90 mmHg or taking antihypertensive drugs)
排除标准
- •Secondary IgA nephropathy
- •Familial IgA nephropathy
- •Concomitant disease: cancer, infection, diabetes mellitus, connective tissue disease, abnormal liver function
- •Pregnancy or breasting
- •Inability to comply with study and follow-up procedures
研究组 & 干预措施
mycophenolate mofetil
mycophenolate mofetil 1.5g/day and maximum tolerated labeled dose of losartan
干预措施: Mycophenolate mofetil (Drug)
losartan
maximus tolerated labeled dose of losartan
干预措施: Losartan (Drug)
结局指标
主要结局
To evaluate the effects of mycophenolate mofetil on a composite renal outcomes in subjects with advanced IgA nephropathy
时间窗: 3 years
Time to the first occurrence of a component of the composite renal endpoint: Doubling of serum creatinine or the onset of end stage renal disease (ESRD) \[needing chronic dialysis or renal transplantation or renal death\]
To evaluate the effects of mycophenolate mofetil on progression of CKD in subjects with advanced IgA nephropathy
时间窗: 3 years
A decrease in eGFR of 30% or more and to a level of less than 60 ml/min at the exit visit if the baseline eGFR was 60 ml/min or more. Or a decrease in eGFR of 50% or more at the exit visit if the baseline eGFR was less than 60 ml/min.
次要结局
- To evaluate the effects of mycophenolate mofetil on the changes of proteinuria in subjects with advanced IgA nephropathy(3 years)
- To evaluate the effects of mycophenolate mofetil rapid progression of CKD in subjects with advanced IgA nephropathy(3 years)
研究者
Fan Fan Hou
Chief of Division of Nephrology
Nanfang Hospital, Southern Medical University