Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy: a Multicentre, Double-blind, Double-dummy, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,600
- 试验地点
- 88
- 主要终点
- Change in 24-h proteinuria from baseline after treatment
研究概览
简要总结
-IgA nephropathy is the most common primary glomerular disease in China, Huangkui Capsule is a single medicament of traditional Chinese medicine consists of Abelmoschus manihot and has been widely used to treat kidney disease. The purpose of this study is to evaluate the safety and efficacy of Abelmoschus manihot for treating IgA nephropathy in large scale samples with long time take.
详细描述
The test has not been completed .
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
- Double (Participant, Care Provider)
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
- •Clinical diagnosed as chronic nephritic syndrome
- •IgA nephropathy diagnosed by kidney biopsy
- •Aged from 18 to 65 years，male or female
- •Blood pressure of ≤140/90mmHg
- •Estimated Glomerular Filtration Rate (eGFR)≥45ml/min/1.73 m2
- •24-hour proteinuria ranged between 0.5g-3.0g
- •Obtaining the signed informed consent from patients
排除标准
- •Secondary IgA nephropathy
- •Be allergic to Huangkui Capsule or Losartan potassium tablet
- •Taken Huangkui Capsule or ACEI or ARB in last 6 weeks
- •Taken the glucocorticoids, immunosuppressants or common threewingnut root and such as drugs with immunosuppressive actions in the last 12 months
- •Blood pressure <90/60mmHg
- •Serum potassium level > 5.5mmol / L
- •Serum albumin level <30g / L
- •Lactation, pregnancy or plans pregnancy during the study period
- •Unilateral or bilateral renal artery stenosis
- •Combined with severe primary diseases of heart, brain, liver and hematopoietic system and so on, or other serious diseases which can affect the patient's life
- •Participating in another clinical study in the same period
研究组 & 干预措施
Abelmoschus manihot (AM)
Abelmoschus manihot (AM): Huangkui capsule (Jiangsu Suzhong Pharmaceutical Group Co., Ltd.), 0.5 g × 30 capsules/box. A huangkui capsule is a single plant drug extract of Flos Abelmoschus manihot.
干预措施: Abelmoschus manihot (Drug)
Losartan
Losartan potassium (Hangzhou MSD Pharmaceutical Co., Ltd.), 100 mg × 7 capsules/box.
干预措施: Losartan (Drug)
结局指标
主要结局
Change in 24-h proteinuria from baseline after treatment
时间窗: Baseline(week 0), week 4, week 12, week 24, week 36, week 48
次要结局
- Change in estimated glomerular filtration rate (eGFR) from baseline after treatment(Baseline(week 0), week 4, week 12, week 24, week 36, week 48)
- Change in serum creatinine from baseline after treatment(Baseline(week 0), week 4, week 12, week 24, week 36, week 48)
研究者
Chen Xiangmei
professor
Chinese PLA General Hospital