Diabetic Nephropathy Type 2
Conditions
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.
Interventions
DRUGAcetylsalicylic Acid
aspirin 50 mg/d to be taken after dinner (in nonfasting conditions)
DRUGPlacebo
Placebo 50 mg/d to be taken after dinner (in nonfasting conditions)
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed