[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521349":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":29,"collaborators":11,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":11,"eligibilityCriteria":37,"healthyVolunteers":33,"sex":38,"minAge":39,"maxAge":40,"enrollmentInfo":41,"targetDuration":11,"studyType":44,"phases":45,"briefSummary":48,"conditions":49,"keywords":11,"overallStatus":51,"whyStopped":11,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":11},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treated group","EXPERIMENTAL",null,[13],"Drug: Acetylsalicylic Acid",{"label":15,"type":16,"description":11,"interventionNames":17},"Comparator group","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Acetylsalicylic Acid","aspirin 50 mg\u002Fd to be taken after dinner (in nonfasting conditions)",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Placebo","Placebo 50 mg\u002Fd to be taken after dinner (in nonfasting conditions)",[15],{"type":30,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100521349","phase-2-study-of-the-protective-effect-of-low-dose-aspirin-on-renal-function-in-patients-with-early-diabetic-nephropathy-100521349",false,"NCT06068439","Study of the Protective Effect of Low-dose Aspirin on Renal Function in Patients With Early Diabetic Nephropathy","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","Inclusion Criteria:\n\n* 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\u002Fg or UAER≥30mg\u002F24h (≥20ug\u002Fmin) in 3 tests within 3\\~6 months. ②. eGFR\\\u003C60ml\u002Fmin\u002F(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\u002Fmin\u002F(1.73m2)-1；\n\nExclusion Criteria:\n\n* (1) History of cardiovascular or cerebrovascular events (defined by the patient's medical history and\u002For instrumental examination results); (2)Insufficient glycemic control (i.e., glycated hemoglobin ≥8%); (3) Uncontrolled blood pressure despite taking antihypertensive drugs (≥140\u002F≥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\\\u003C30 mL\u002Fmin\u002F1.73 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\u002Fsupraventricular 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.","ALL","18 Years","70 Years",{"count":42,"type":43},355,"ESTIMATED","INTERVENTIONAL",[46,47],"PHASE2","PHASE3","This is a multicenter, randomized, placebo-controlled study to evaluate the effectiveness and safety of low-dose aspirin (50 mg\u002Fday) in renal and cardiac function protection in people with diabetic nephropathy.",[50],"Diabetic Nephropathy Type 2","NOT_YET_RECRUITING","2023-09-28",{"date":54,"type":55},"2023-10-05","ACTUAL",{"date":57,"type":43},"2024-01-01",{"date":59,"type":43},"2027-06-30",{"name":5,"class":6}]