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临床试验/NCT01161459
NCT01161459已完成不适用

Research Institute of Nephrology, Jinling Hospital

Zhi-Hong Liu, M.D.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Active Comparator

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

发起方
Zhi-Hong Liu, M.D.
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zhi-Hong Liu, M.D.

professor

Nanjing University School of Medicine

研究点 (1)

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