Huaiqihuang Granules in the Treatment of Primary Glomerulonephritis of Stage CKD3: a Randomized, Double-blind, Double-simulation, Positive Parallel Control Multi-center Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 466
- 试验地点
- 34
- 主要终点
- Rate of change in Estimated Glomerular Filtration Rate (eGFR) compared to baseline
研究概览
简要总结
This is a multicentre prospective, randomized, double-blind and imitation, positive-drug parallel controlled clinical trail. The objective of this study is to evaluate the efficacy and safety of Huaiqihuang Granule in patients with CKD stage 3 primary glomerulonephritis.
详细描述
Chronic kidney disease is a common disease that affects health seriously. In some regions of China, the morbidity of this kind of disease is as high as 10.8%. Primary glomerulopathy is one of the pathogenesis of chronic kidney disease, which occupied 50%-60%. However, at present, there is still a lack of effective means for the treatment of primary glomerulonephritis in CKD stage 3. Huaiqihuang Granule is a kind of Chinese herbal medicine compound preparation, Previous researches showed that Huaiqihuang has a comprehensive effect on primary glomerulonephritis. In this study, there were about 40 first-class hospitals participating in. We planned to enroll 466 participants, who will be randomly divided into the Huaiqihuang Granule group (experimental group) and the Valsartan group (control group). All participants will take medication for 48 weeks, and investigators will follow up participates at weeks 0, 8,16, 24, 32, 40, 48.
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, Investigator)
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
- •Diagnosed as primary glomerulonephritis by renal biopsy
- •Male or female, 18≤age≤65
- •Blood pressure can be effectively controlled at or below 140/90mmHg
- •30mL/（min.1.73m2）≤ eGFR<60mL/（min.1.73m2）
- •24-hour urine protein ration ≤ 2.0g/24h
- •The participants must be capable of understanding and comply with the protocol and sign a written informed consent document
排除标准
- •Diagnosed as secondary glomerulonephritis
- •Exposure to corticosteroids, immunosuppressors, tripterygium glycosides, ARBs or ACEIs, without a two weeks washout period
- •Blood pressure < 90/60 mmHg
- •Serum potassium > 5.5 mmol/L
- •Serum albumin < 30g/L
- •Unilateral or bilateral renal artery stenosis
- •Pregnant or lactating women, and participants (including males) who were unable or unwilling to take adequate contraception during the study period
- •Having comorbidities that affect the progression of primary glomerulonephritis (including but not limited to Malignant tumors, Systemic autoimmune diseases, Liver cirrhosis, Diabetes, and Gout)
- •Allergic to the Huaiqihuang Granule or valsartan
- •Participating in another clinical trial
- •Investigators do not think it suitable for a participant to join this study
研究组 & 干预措施
Huaiqihuang group
Combine the use of Huaiqihuang granules and Valsartan capsule simulant.
干预措施: Huaiqihuang granules (Drug)
Valsartan Group
Combine the use of Valsartan capsule and Huaiqihuang granules simulant.
干预措施: Valsartan capsule (Drug)
结局指标
主要结局
Rate of change in Estimated Glomerular Filtration Rate (eGFR) compared to baseline
时间窗: 48 weeks
Events based on eGFR measure compared to baseline calculated using the CKD-EPI formula.
次要结局
- Change in 24-hour urine protein ration from baseline.(Start of treatment until the end of the treatment for 48 weeks)
- Change in serum creatinine levels from baseline(Start of treatment until the end of the treatment for 48 weeks)
- Changes in urine erythrocyte levels from baseline(Start of treatment until the end of the treatment for 48 weeks)