Research Institute of Nephrology, Jinling Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The number of CR and PR of Tripterygium wilfordii plus steroid in the treatment of membranous nephropathy
研究概览
简要总结
The purpose of this study is: To explore the potential role of Tripterygium wilfordii plus steroid in the treatment of membranous nephropathy.
To investigate the safety and tolerability of Tripterygium wilfordii plus steroid
详细描述
Idiopathic membranous nephropathy is the most common cause of nephrotic syndrome in adults. Over the past decade, a number of studies have reported therapeutic efficacy for treatment with tacrolimus plus steroid in patients with nephrotic syndrome including patients with membranous nephropathy. This study will evaluate the safety and effectiveness of a traditional herbal extraction, Tripterygium wilfordii, plus steroid in reducing the amount of protein in the urine in patients with membranous nephropathy. A hundred patients with biopsy-proven membranous nephropathy will be recruited. They will be screened with a medical history, physical examination, blood tests, and an examination for infection, cancers, and other conditions that can cause membranous nephropathy. The investigators plan to conduct an open-label study of the efficacy and safety of Tripterygium wilfordii in the treatment of membranous nephropathy. Half of them will be treated with oral Tripterygium wilfordii plus steroids for 6 months, followed by 6 months of maintenance, and the other half treated with tacrolimus plus steroid as positive contrast. Proteinuria, renal function will be monitored. Complete remission is defined as 24-hour urinary protein excretion to less than 0.4 mg/day and serum albumin>35g/L. This study will explore the potential role of Tripterygium wilfordii in the treatment of membranous nephropathy, it's cost less .
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 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven idiopathic membranous nephropathy
- •Nephrotic syndrome with proteinuria ( > 3.5 g/day) and serum albumin < 30 g/dl
- •Age 18-65 years with informed consent
排除标准
- •Patient with elevated serum creatinine concentration
- •Prior therapy with sirolimus, CSA, MMF, or azathioprin, cytoxan, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days
- •Active/serious infection
- •Patient with hepatitis B surface antigen or who is hepatitis C antibody positive
- •Patient who is diabetic
- •Patient is allergic or intolerant to macrolide antibiotics or tacrolimus
研究组 & 干预措施
Tripterygium wilfordii
120mg/d for 6 months,then decrease to 60mg/d by 30mg/d every month for 12 months
干预措施: Tripterygium wilfordii (Drug)
FK506
干预措施: FK506 (Drug)
结局指标
主要结局
The number of CR and PR of Tripterygium wilfordii plus steroid in the treatment of membranous nephropathy
时间窗: 18 months
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerabilitysteroid(18 months)
研究者
Zhi-Hong Liu, M.D.
professor
Nanjing University School of Medicine
