NCT04349683Unknown4 期
Efficacy and Safety of Jinshuibao for Patients With Chronic Kidney Disease Due to Glomerulonephritis：A Multicenter Randomized Controlled Clinical Trial
Jemincare0 个研究点目标入组 332 人开始时间: 2020年4月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 332
- 主要终点
- Change of estimated glomerular filtration rate
研究概览
简要总结
This is a multicenter, double-blind randomized controlled study to assess the efficacy and safety of Jinshuibao for patients with CKD due to glomerulonephritis, with a planned follow-up of 48 weeks.
详细描述
Previous studies have shown that cordyceps sinensis can act on several immune response pathways. Jinshuibao capsule, which is composed of fermented cordyceps sinensis powder (Cs-4) , has shown therapeutic effects in chronic kidney disease (CKD) according to small sample exploratory studies. Here, we conduct a prospective, double-blind randomized controlled study to assess the efficacy and safety of Jinshuibao for patients with CKD due to glomerulonephritis.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged >= 18 years old and <= 70 years old.
- •Patients with chronic kidney disease caused by primary glomerulonephritis diagnosed by previous pathology or diagnosed by clinician.
- •Chronic kidney disease stage 3b-4, that is, patients with eGFR between 15 and 45 ml/min per 1.73 m2 (according to 2012 KDIGO standard).
- •24-hour urinary protein < 3g during the screening period.
- •Blood pressure, glucose, lipid and uric acid were measured during the screening period and were all in the following range: blood pressure: systolic blood pressure <140 and diastolic blood pressure < 90 mmHg; fasting blood-glucose < 8.0mmol/L or HbA1c < 8.0%; LDLl-c < 100 mg /dl (2.59 mmol/L), and TC < 230 mg /dl (5.95 mmol/L); uric acid < 420 mol/L.
- •Patients who have signed the informed consent.
排除标准
- •Pregnant or lactating women, or women of reproductive age who are unwilling to take reliable contraceptive measures.
- •Allergy to Jinshuibao.
- •Treatment with natural cordyceps sinensis, artificial cordyceps sinensis, traditional Chinese medicine or proprietary Chinese medicine with known renal impairment in recent 2 weeks.
- •Treatment with glucocorticoids, immunosuppressants or tripterygium wilfordii preparations in recent 3 months, or patients who have been confirmed to be treated with glucocorticoids, immunosuppressants or tripterygium wilfordii preparations in the following months.
- •History of gastrointestinal impairment or gastrointestinal diseases which may significantly affect the absorption of the experimental drugs, such as confirmed active ulcer (Forrest grade II or more severe impairment), inflammatory bowel disease, malabsorption syndrome, uncontrollable diarrhea or history of gastrointestinal surgery.
- •History of organ transplant, including kidney transplant.
- •History of severe diseases of the heart, brain, liver, hematopoietic system or other serious diseases affecting survival, such as malignant tumors, myocardial infarction, unstable angina, stroke or transient ischemic attack in recent 6 months.
- •Patients whose disease progresses too rapidly judged by the clinician.
- •Enrolled in other trials in recent 3 months.
- •Patients who are assessed by investigator as unsuitable for inclusion.
研究组 & 干预措施
Experimental group
Experimental
basic treatment combined with Jinshuibao
干预措施: Jinshuibao (Drug)
Control group
Placebo Comparator
basic treatment and placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change of estimated glomerular filtration rate
时间窗: Baseline to 48 weeks
Estimated Glomerular Filtration Rate (eGFR) will be calculated according to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) creatinine equation
次要结局
- Change of TNF-α, IL-1β, and IL-6(Baseline to 24 weeks and 48 weeks)
- Change of surem creatinine and 24-hour urine protein(Baseline to 12 weeks, 24 weeks, 36 weeks, 48 weeks)
- Change of urinary protein/creatinine ratio (PCR)(Baseline to 12 weeks, 24 weeks, 36 weeks, 48 weeks)
- Change of hs-CRP(Baseline to 24 weeks, 48 weeks)
- Time to decline of 50% in eGFR or development of ESRD, and incidence of decline of 50% in eGFR or development of ESRD(48 weeks)
- Patients' Quality of life(Baseline to 24 weeks and 48 weeks)
- Number of rehospitalizations(48 weeks)
研究者
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