Low Steroid Dose Combined With Mycophenolic Acid (Myfortic) Compared With High Dose Steroid for Minimal Change Nephrotic Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- complete remission
研究概览
简要总结
A multicenter, randomized, study will be performed to evaluate the efficacy of low dose steroid combined with mycophenolic acid (MyforticR) versus high dose steroid in inducing remission in adults with minimal change nephrotic syndrome (MCNS). One hundred and fourteen patients (CPP decision 2009-04-02-a5) will be included in this study. They will be randomly assigned to an open label treatment with either prednisone
1 mg/kg/day (arm A) or 0,5 mg/kg/day plus myforticR 1440 mg/day (arm B) for four weeks. The outcome will be compared during one-year follow up
详细描述
The treatment for minimal change nephrotic syndrome (MCNS) is empirically based on high dose steroid. However, the side effects in adult patients are often significant and induce a lot of complications. This prospective study aimed to compare low dose steroid combined with mycophenolic acid (MyforticR) versus high dose steroid in the treatment of the first episode of MCNS.
Treatment Plan
After baseline evaluation including clinical biological and histological analyses, all eligible patients will be an open label assigned to two groups:
Group A: patients will receive prednisone 1 mg/kg/day for 4 weeks. Then, the dose will be progressively tapered if the remission will be achieved. For patients who exhibit incomplete remission at this time, high dose steroid will be continued for 4 weeks again before the tapering.
Group B: patients will receive prednisone 0.5 mg/kg/day combined with mycophenolic acid (MyforticR) 1440 mg/day. The management of steroid therapy will be identical in both groups, while MyforticR will be continued for six months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic nephrotic syndrome
- •Flare of idiopathic syndrome without treatment from one year
- •Confirming by Renal Biopsy
排除标准
- •Secondary nephrotic syndrome
- •Pregnancy
- •Focal Segmental Glomerular sclerosis lesion in the Biopsy
- •Neutropenia < 2000/mm3
- •Hb<9gr/dl
研究组 & 干预措施
B-Experimental
Experimental
干预措施: acid mycophenolic (Myfortic) (Drug)
A-Active Comparator
Active Comparator
干预措施: Prednisone (Drug)
结局指标
主要结局
complete remission
时间窗: within 4 weeks
complete remission
次要结局
- complete remission(within 8 weeks)
- partial remission(within 4 and 8 weeks)
- Adverse effects in both arms(1 year)
- Number of flare in both arms(at 1 year)