Phase 3 Study of Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of patients reaching remission
研究概览
简要总结
The purpose of this study is to determine whether Multi-glycoside of Tripterygium Wilfordii HOOK. f. is effective and safe in the treatment of IgA nephropathy.
详细描述
Primary IgA nephropathy (IgAN) is the most common form of idiopathic glomerulonephritis throughout of the world. The disease is characterized by the predominant deposition of polymer Gal-deficient IgA1 immune complex（pGd-IgA1-IC）in the glomeruli which leads to the proliferation of mesangial cells. Mycophenolate mofetil is reported to be useful in the treatment of IgAN in Chinese patients, but the price is expensive together with some adverse events. Tripterygium Wilfordii HOOK. f. is a traditional chinese medicine and is useful in the treatment of CKD, the purpose of this study is to determine whether Multi-glycoside of Tripterygium Wilfordii HOOK. f. is effective and safe in the treatment of IgA nephropathy
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
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •urinary protein levels ≥1.0 g/24 h
- •estimated glomerular filtration rate (eGFR) ≥30 ml·min-1·1.73 m-2body surface area by the MDRD formula (eGFR=194×age-0.287×serum creatinine
- •1.094(×0.739, if female) (where sCr is the serum creatinine, dry chemistry method, mg/dl))
- •peripheral blood white blood cell count ≥3000×109/L
- •no other cause for tubulointerstitial lesions
- •no history of immunomodulatory agent intake before renal biopsy
- •no systemic infection
- •age between 16 and 65 years
排除标准
- •severe infections
研究组 & 干预措施
TWH for the treatment of IgAN
Interventions :The dosage of 40 mg of Multi-glycoside of Tripterygium Wilfordii HOOK. f. was divided into 2 equal doses at 12-hour intervals for 6 months.
干预措施: Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH) (Drug)
MMF for IgAN
MMF for the treatment of IgAN for 6 months
干预措施: Mycophenolate mofetil (MMF) (Drug)
结局指标
主要结局
Number of patients reaching remission
时间窗: one year
(i) complete remission was defined as the absence of proteinuria (24-h urine protein \< 0.4 g/24 h), serum albumin \>35 g/L and Scr \< 1.24 mg/ dL; (ii) partial remission was defined as a 24-h urine protein ≤ 3.5 g/24 h and a decline of \>50% of the baseline value with an Scr elevation of \<15% of the baseline value; (iii) no response was defined as a 24-h urine protein \>3.5 g/24h, or a decline \< 50% of base- line value or increase and/or an Scr level \>50% of the baseline value
次要结局
- Renal survival(one year)
研究者
Youming Peng
Director of the Nephrology Institute
Second Xiangya Hospital of Central South University