Myfortic® Combined With Low-dose Steroid in Minimal Change Nephrotic Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Complete remission (24 hour urine protein < 0.3 g)
研究概览
简要总结
Study objective: To investigate the potential therapeutic efficacy of enteric-coated mycophenolate sodium combined with low-dose corticosteroid as first-line treatment for minimal change nephrotic syndrome (MCNS).
详细描述
This is a prospective, open-label, randomized study in which patients who present for the first time with a clinical diagnosis of idiopathic MCNS proven on renal biopsy will be assigned to either conventional standard-dose prednisolone monotherapy or myfortic combined with low-dose prednisolone treatment for 6 months. Clinical response and relapse rates within 6 months of treatment cessation will be the main outcome parameters.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18 - 65 years of age
- •First histologic diagnosis of MCNS
- •Proteinuria > 3.5 g/day
- •Patients who are willing to give written, informed consent
排除标准
- •Presence of secondary causes of MCNS
- •History of glomerular disease including MCNS
- •eGFR < 50 ml/min/1.73m2
- •Renal histology showing pathologies other than MCNS
- •Female of child-bearing age who are unwilling to practice effective contraception
- •Patients simultaneously participating in another study or who have participated in another study within the last 30 days of entry into this study
研究组 & 干预措施
Myfortic plus low-dose steroid
Not necessary
干预措施: Myfortic plus low-dose steroid (Drug)
Standard-dose steroid
Not necessary
干预措施: Prednisolone (Drug)
结局指标
主要结局
Complete remission (24 hour urine protein < 0.3 g)
时间窗: at 6 months
次要结局
- Occurrence of cushingoid facies, striae, acne, weight gain, GI disturbance, cytopenia, infection(at 6 months)