Prednisone Plus Tripterygium Wilfordii Treatment of Adult Patients With Idiopathic Focal Segmental Glomerulosclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- To assess the efficacy and safety of TW in the treatment of FSGS
研究概览
简要总结
The purpose of this study is to assess the efficacy of prednisone and tripterygium wilfordii in treated Focal Segmental Glomerulosclerosis (FSGS).
详细描述
Primary FSGS is a leading cause of end stage renal disease in adults, with complete loss of kidney function in 50% of patients over 10 years. Steroids, which are currently used to treat the disease, are effective in part of patients. Over the past decade, a number of studies have reported therapeutic efficacy for treatment with high-dose and over 6mo prednisone in patients with FSGS. These studies show that the total effective rates were only around 50%. But this therapy had taken some side effects of prednisone. Except these studies, in recent studies suggest that Tripterygium Wilfordii may be effective for passive Heymann nephritis, podocyte injury in nephrosis rats induced y puromycin aminonucleoside, and so on. FSGS is a podocytepathy. There was no-data of Prednisone and Tripterygium Wilfordii treatment of Chinese adult patients with idiopathic FSGS.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years at onset of signs or symptoms of FSGS
- •Urine protein ≥ 3.5 g/24 h
- •Estimated glomerular filtration rate (GFR) ≥ 40 ml/min/1.73 m2, serum creatinine<2.5mg/dl
- •Biopsy confirmed as idiopathic FSGS (including all subtypes)
- •Willingness to follow the clinical trial protocol, including medications, and baseline and follow-up visits and procedures
排除标准
- •Secondary FSGS
- •Prior therapy with sirolimus, Cyclosporine, MMF, azathioprin, cytoxan, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days
- •Active/serious infection
- •Malignancy
- •Previously diagnosed as diabetes mellitus type 1 or 2, or abnormal carbohydrate tolerance
- •Peripheral white blood cells < 3000/ul
- •Clinical evidence of cirrhosis or chronic active liver diseases
- •History of significant gastrointestinal disorder
- •Allergy to study medications, and Inability to consent/assent
研究组 & 干预措施
Large pred
Prednisone 60mg/d*8 wks
干预措施: tripterygium wilfordii (TW) (Drug)
small pred
Pred 30mg/d*8wks
干预措施: tripterygium wilfordii (TW) (Drug)
结局指标
主要结局
To assess the efficacy and safety of TW in the treatment of FSGS
时间窗: 12 months
次要结局
未报告次要终点