NCT06068439尚未招募2 期
A Phase III Multi-center Randomized Placebo-controlled Study of the Protective Effect of Low-dose Aspirin on Renal Function in Patients With Early Diabetic
Second Affiliated Hospital, School of Medicine, Zhejiang University0 个研究点目标入组 355 人开始时间: 2024年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 355
- 主要终点
- decline of renal function
研究概览
简要总结
This is a multicenter, randomized, placebo-controlled study to evaluate the effectiveness and safety of low-dose aspirin (50 mg/day) in renal and cardiac function protection in people with diabetic 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
- 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
- •1.Voluntarily sign informed consent;2.Meet the diagnosis of diabetic nephropathy: In the case of identifying diabetes as the cause of kidney damage and excluding chronic kidney disease caused by other causes, at least one of the following is present:①. In the case of excluding interference factors, at least 2 UACR≥30mg/g or UAER≥30mg/24h (≥20ug/min) in 3 tests within 3~6 months. ②. eGFR<60ml/min/(1.73m2)-1 for more than 3 months. ③. Renal biopsy consistent with pathological changes of DKD;3.DKD staging is 3 and before，eGFR>30ml/min/(1.73m2)-1；
排除标准
- •(1) History of cardiovascular or cerebrovascular events (defined by the patient's medical history and/or instrumental examination results); (2)Insufficient glycemic control (i.e., glycated hemoglobin ≥8%); (3) Uncontrolled blood pressure despite taking antihypertensive drugs (≥140/≥85mmHg); (4) Previous major bleeding (i.e., intracranial hemorrhage); (5) Previous gastrointestinal ulcers; (6) Clinical diagnosis of type 1 diabetes mellitus (diagnosis of diabetes mellitus and use of insulin before age 35);(7) Patients with CKDG4 or G5 (i.e., eGFR<30 mL/min/1.73 m2 or dialysis) ;(8) chronic active infection or; (9) evidence of malignancy within the past 5 years. Patients with tumour disease in situ who are successfully treated only by local resection can be included in the study (including non-melanoma skin cancer in situ); (10) Autoimmune diseases; (11) Persistent arrhythmias requiring anticoagulation therapy (i.e., atrial fibrillation). In this category, isolated ventricular/supraventricular presystoles; (12) Use of NSAIDs or other antiplatelet drugs in the past 30 days; (13) cirrhosis of any etiology; (14) use of anticoagulants; (15) Life expectancy less than 1 year; (16) Known aspirin allergy; (17) Known pregnancy; and (18) Severe mental illness.
研究组 & 干预措施
Treated group
Experimental
干预措施: Acetylsalicylic Acid (Drug)
Comparator group
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
decline of renal function
时间窗: 3YEARS
The aim of the study is to evaluate the decline of renal function, as assessed by absolute change in eGFR, calculated as the difference between eGFR at 3 years and baseline eGFR, in T2DM patients receiving low-dose aspirin (50 mg/d) or lacebo.
次要结局
- The rapid decline in renal function(3YEARS)
- Change of renal function class(3YEARS)
研究者
相似试验
已完成
3 期
Phase III Clinical Study Evaluating the Efficacy and Safety of WPV01 in Patients With Mild/Moderate COVID-19Mild to Moderate COVID-19NCT06197217Westlake Pharmaceuticals (Hangzhou) Co., Ltd.1,350
已完成
3 期
Study to Evaluate the Safety and Efficacy of Jaktinib in Adults With Alopecia AreataAlopecia AreataNCT05051761Suzhou Zelgen Biopharmaceuticals Co.,Ltd425
已完成
3 期
A Clinical Trial to Evaluate the Safety, Efficacy, and Immunogenicity of DR-5001Respiratory Tract DiseasesNCT00382408Duramed Research4,040
Unknown
3 期
A Study Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy in Untreated Metastatic Breast Cancer (RIBBON 1)Metastatic Breast CancerNCT00262067Genentech, Inc.1,237
撤回
3 期
A Safety and Efficacy Trial of Dapivirine Vaginal Ring in AfricaHIV InfectionsNCT01337583International Partnership for Microbicides, Inc.