Study of the Protective Effect of Low-dose Aspirin on Renal Function in Patients With Early Diabetic Nephropathy
Phase 2
Not yet recruiting
- Conditions
- Diabetic Nephropathy Type 2
- Interventions
- Drug: Placebo
- Registration Number
- NCT06068439
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 355
Inclusion Criteria
- 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；
Exclusion Criteria
- (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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comparator group Placebo - Treated group Acetylsalicylic Acid -
- Primary Outcome Measures
Name Time Method decline of renal function 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.
- Secondary Outcome Measures
Name Time Method The rapid decline in renal function 3YEARS The rapid decline in renal function, defined as a reduction of eGFR ≥5 mL/min at 1 year
Change of renal function class 3YEARS Change of renal function class (from G1 to G2, from G2 to G3a, and so on) at 3 years, dialysis, or transplantation