Study of the Protective Effect of Low-dose Aspirin on Renal Function in Patients With Early Diabetic Nephropathy

Diabetic Nephropathy Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06068439
• Other study ID #: SZNK2
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: January 1, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: September 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 355
• Est. completion date: June 30, 2027
• Est. primary completion date: January 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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:?. 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. ?. eGFR<60ml/min/(1.73m2)-1 for more than 3 months. ?. 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.

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy Type 2
• Kidney Diseases

Intervention

Drug:
• Acetylsalicylic Acid
aspirin 50 mg/d to be taken after dinner (in nonfasting conditions)
• Placebo
Placebo 50 mg/d to be taken after dinner (in nonfasting conditions)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decline of renal function	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.	3YEARS
Secondary	The rapid decline in renal function	The rapid decline in renal function, defined as a reduction of eGFR =5 mL/min at 1 year	3YEARS
Secondary	Change of renal function class	Change of renal function class (from G1 to G2, from G2 to G3a, and so on) at 3 years, dialysis, or transplantation	3YEARS