[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635620":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":30,"centralContacts":38,"locations":44,"responsibleParty":60,"collaborators":30,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":30,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":30,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":83,"whyStopped":30,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Jiangsu Hansoh Pharmaceutical Co., Ltd.","INDUSTRY",[8,13,16,19],{"label":9,"type":10,"description":9,"interventionNames":11},"HS-10390 Dose A","EXPERIMENTAL",[12],"Drug: HS-10390",{"label":14,"type":10,"description":14,"interventionNames":15},"HS-10390 Dose B",[12],{"label":17,"type":10,"description":17,"interventionNames":18},"HS-10390 Dose C",[12],{"label":20,"type":21,"description":22,"interventionNames":23},"Irbesartan","ACTIVE_COMPARATOR","Irbesartan will be administered daily as a 150-mg oral tablet. Irbesartan will be administered daily as a 150-mg orally for the first 2 weeks of the study following randomization. For patients who tolerate the initial dose of 150 mg after 2 weeks will increase their dose to 300 mg.",[24],"Drug: Irbesartan",[26,31,33,35],{"type":27,"name":28,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","HS-10390",[9],null,{"type":27,"name":28,"description":28,"armGroupLabels":32,"otherNames":30},[14],{"type":27,"name":28,"description":28,"armGroupLabels":34,"otherNames":30},[17],{"type":27,"name":20,"description":36,"armGroupLabels":37,"otherNames":30},"Target dose of 300 mg daily",[20],[39],{"name":40,"role":41,"phone":42,"phoneExt":30,"email":43},"Wei Chen Professor, MD","CONTACT","13924150966","Emailwchen66@qq.com",[45],{"facility":46,"status":30,"city":47,"state":48,"zip":30,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"The First Affiliated Hospital,Sun Yat-sen University","Guangzhou","Guangdong","China","CN",{"type":52,"coordinates":53},"Point",[54,55],113.25,23.11667,{"lat":55,"lon":54},[58],{"name":59,"role":41,"phone":42,"phoneExt":30,"email":43},"Wei Chen WC archiater, Doctor",{"type":61,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100635620","phase-2-a-study-of-the-effect-and-safety-of-hs-10390-in-the-treatment-of-participants-with-chronic-kidney-disease-100635620",false,"NCT07555054","A Study of the Effect and Safety of HS-10390 in the Treatment of Participants With Chronic Kidney Disease","A Randomized, Multicenter, Double-blind, Parallel Active-control Study of the Efficacy and Safety of HS-10390 for the Treatment of Participants With Chronic Kidney Disease","Inclusion Criteria:\n\n1. Men and women aged 18-70 years old;\n2. Body mass index (BMI) ≥18.0 and \\\u003C50.0 kg\u002Fm\\^2 at screening;\n3. Currently on stable dose (maximum tolerated dose and at least one-half of the maximum labeled dose) of ACEI and\u002For ARB therapy for at least 4 weeks and treated for at least 3 months prior to the screening visit;\n4. Diagnosed with chronic kidney disease, and the estimated glomerular filtration rate (eGFR) was ≥30 and \\\u003C90 mL\u002Fmin\u002F1.73 m\\^2 calculated using the 2021 CKD-EPI creatine formula at screening;\n5. Urinary albumin\u002Fcreatinine ratio (UACR) was ≥300 and \\\u003C3000 mg\u002Fg for at least 2 times on different days detected by the local laboratory at screening;\n6. Systolic BP between 90 and 160 mmHg and diastolic BP between 60 and 100 mmHg;\n7. Agree to contraception.\n\nExclusion Criteria:\n\n1. A known or suspected allergy to the investigational medical drug or its components or excipients;\n2. Within 4 weeks before screening, the following drugs could not maintain the stable regimen: diabetes drugs, hypertension drugs, non-steroidal anti-inflammatory drugs;\n3. If glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are prescribed, the dose are unstable within 8 weeks before screening ;\n4. Participants with uncontrolled diabetes mellitus (HbA1c \\> 8%);\n5. Received any other study drug treatment within 30 days or 5 half-lives (whichever is longer) prior to screening;\n6. Polycystic kidney disease, lupus nephritis, anti-neutrophil cytoplasmic antibody (ANCA) -associated vasculitis, acute glomerulonephritis, bilateral renal artery stenosis;\n7. Acute kidney injury or dialysis treatment within 6 months before screening;\n8. Received kidney transplant, or plan to receive kidney transplant during the trial;\n9. Platelet\\\u003C 100×10\\^9\u002FL or hemoglobin value \\\u003C 90 g\u002FL or Hematocrit value \\\u003C 27% (0.27 V\u002FV) at screening;\n10. Elevations of transaminases (ALT and\u002For AST) \\>3 times upper limit of normal (ULN) or total bilirubin exceeding 1.5 times the upper limit of normal at screening;\n11. Serum potassium \\>5.5 mmol\u002FL at screening.","ALL","18 Years","70 Years",{"count":73,"type":74},182,"ESTIMATED","INTERVENTIONAL",[77],"PHASE2","The purpose of the study was to evaluate the efficacy and safety of HS-10390 in participants with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) ≥ 30 and \\\u003C90 mL\u002Fmin\u002F1.73 m\\^2, and urinary albumin to creatinine ratio (UACR) ≥ 150 mg\u002Fg and \\\u003C 3000 mg\u002Fg",[80],"Chronic Kidney Disease",[82],"chronic kidney disease","NOT_YET_RECRUITING","2026-04-21",{"date":86,"type":87},"2026-04-28","ACTUAL",{"date":89,"type":74},"2026-05-21",{"date":91,"type":74},"2028-12-31",{"name":5,"class":6},1]