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NCT Number: NCT06068439

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

acetylsalicylic acid

Drug

aspirin 50 mg/d to be taken after dinner (in nonfasting conditions)

Placebo

Drug

Placebo 50 mg/d to be taken after dinner (in nonfasting conditions)

Primary outcomes

  1. decline of renal function

    Time frame: 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 outcomes

  1. The rapid decline in renal function

    Time frame: 3YEARS

    The rapid decline in renal function, defined as a reduction of eGFR ≥5 mL/min at 1 year

  2. Change of renal function class

    Time frame: 3YEARS

    Change of renal function class (from G1 to G2, from G2 to G3a, and so on) at 3 years, dialysis, or transplantation

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 5, 2023
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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