A Prospective, Randomized, Open-label Study Evaluating the Efficacy of Mycophenolate Mofetil in the Prevention of Relapse of Steroid Dependent Nephrotic Syndrome in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- relapse free time
研究概览
简要总结
Idiopathic nephrotic syndrome is generally responsive to steroid therapy, but some patients need other immunosuppressants to reduce steroid dependency. The long-term use should be restricted due to adverse effects of cyclosporine, such as hypertension and nephrotoxicity.
Mycophenolate mofetil for steroid-dependent nephrotic syndrome has been reported to have similar efficacy and fewer undesirable effects to other drugs in mainly observational studies. To determine the efficacy of mycophenolate mofetil in the management of steroid-dependent nephrotic syndrome, the investigators designed this prospective randomized controlled study.
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
- 2 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Steroid-dependent patients who had been on calcineurin inhibitors continuously for more than 1 year
- •in complete remission
排除标准
- •Hereditary or secondary nephrotic syndrome
- •Estimated glomerular filtration rate (GFR) < 60 mg/min/1.73 m^2
- •Body weight <16 kg
- •leukocytopenia (absolute neutrophil count < 2000/mm^3) or anemia(Hct < 25%)
- •Severe gastrointestinal disease
- •chronic or acute active infection (e.g. hepatitis B,C, herpes, varicella zoster)
- •prior live vaccine inoculation within 6 weeks (from the study enrollment)
- •GOT/GPT elevation or hyperbilirubinemia
- •malignant disease
- •Pregnant or Breast feeding
- •Previous history of mycophenolate mofetil use
- •Participation to other therapeutic trial within recent 3 months
- •Deficiency of the enzyme hypoxanthine-guanine phosphoribosyltransferase
研究组 & 干预措施
Mycophenolate mofetil
干预措施: Mycophenolate mofetil (Drug)
结局指标
主要结局
relapse free time
时间窗: 1 year
次要结局
- adverse effect(1 year)
研究者
Hee Gyung Kang
Associate professor
Seoul National University Hospital