RCT Study on the Efficacy and Safety of a Novel Tripterygium Wilfordii Preparation in Reducing Proteinuria in Patients With Diabetic Nephropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Urinary protein remission rate, %
研究概览
简要总结
The investigators designed a randomized parallel controlled clinical study, selected 98 cases of diabetic nephropathy patients with urinary protein > 1g, randomly assigned into the Kunxian capsule + irbesartan group or irbesartan group, 48 weeks of treatment and follow-up, reduced levels of urinary protein and effective relief time, remission rate as the main end point, estimated glomerular filtration rate (eGFR) drop rate slope for secondary end points, safety events were also collected. To evaluate the efficacy and safety of Kunxian capsule combined with irbesartan in treatment of diabetic nephropathy compared with irbesartan alone.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Conformed to the diagnostic criteria of diabetic nephropathy
- •No gender limitation, age 18-85 years old, no fertility requirement temporarily
- •eGFR: >30ml/min/1.73m2（CKD-EPI）
- •Urine protein >1 g/day
- •No glucocorticoids or/and immunosuppressive therapy was received within 3 months
- •Patients volunteered to participate in this study and signed the informed consent
排除标准
- •Combined with diabetic acute complications or acute kidney injury (AKI)
- •Combined with other autoimmune diseases
- •Primary and other secondary renal diseases
- •Patients with hypotension (BP < 90/60mmHg) or bilateral renal artery stenosis who are not suitable for angiotensin receptor blockers (ARB) drugs
- •There are contraindications to the use of kunxian capsules or allergic to any of the ingredients in kunxian capsules
- •There are fertility requirements or pregnant, lactation patients
- •Combined with malignant tumor, hepatitis, tuberculosis, HIV, serious infection, rheumatic disease, heart failure, chronic obstructive pulmonary disease (COPD) and other serious systemic diseases
- •Kidney transplant or dialysis has been performed
- •Clinicians deem it inappropriate, or patients are unwilling to sign informed consent, have poor compliance, have a history of mental illness, or cannot complete follow-up visits
研究组 & 干预措施
Experimental group
Kunxian capsule (2# tid or 2# bid) + irbesartan tablet (150mg qd or 300mg qd) for 48 weeks
干预措施: Kunxian capsule (Drug)
结局指标
主要结局
Urinary protein remission rate, %
时间窗: 48 weeks
Changed levels of urinary protein, gram
时间窗: 48 weeks
The effective remission time of urinary protein, day
时间窗: 48 weeks
次要结局
- eGFR decline rate slope(48 weeks)
- Number of participants achieving end stage renal disease (ESRD) or requiring dialysis or kidney transplantation, or blood creatinine doubling, or renal death, or all-cause death, %(48 weeks)
- Time of participants achieving end stage renal disease (ESRD) or requiring dialysis or kidney transplantation, or blood creatinine doubling, or renal death, or all-cause death, days(48 weeks)
- Urinary albumin/creatinine ratio(48 weeks)
- 24-hour urinary protein quantity, gram(48 weeks)