search
Back to results

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

Primary Purpose

Diabetic Nephropathy Type 2

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Acetylsalicylic Acid
Placebo
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathy Type 2

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Treated group

    Comparator group

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    September 28, 2023
    Last Updated
    September 28, 2023
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06068439
    Brief Title
    Study of the Protective Effect of Low-dose Aspirin on Renal Function in Patients With Early Diabetic Nephropathy
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    January 30, 2027 (Anticipated)
    Study Completion Date
    June 30, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Nephropathy Type 2

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    355 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treated group
    Arm Type
    Experimental
    Arm Title
    Comparator group
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Acetylsalicylic Acid
    Intervention Description
    aspirin 50 mg/d to be taken after dinner (in nonfasting conditions)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo 50 mg/d to be taken after dinner (in nonfasting conditions)
    Primary Outcome Measure Information:
    Title
    decline of renal function
    Description
    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.
    Time Frame
    3YEARS
    Secondary Outcome Measure Information:
    Title
    The rapid decline in renal function
    Description
    The rapid decline in renal function, defined as a reduction of eGFR ≥5 mL/min at 1 year
    Time Frame
    3YEARS
    Title
    Change of renal function class
    Description
    Change of renal function class (from G1 to G2, from G2 to G3a, and so on) at 3 years, dialysis, or transplantation
    Time Frame
    3YEARS

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs