[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635620":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":11,"studyPopulation":11,"armGroups":39,"interventions":57,"overallOfficials":11,"centralContacts":69,"locations":75,"responsibleParty":91,"collaborators":11,"id":93,"slug":11,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":11,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":11,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":113,"whyStopped":11,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Jiangsu Hansoh Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Urinary Albumin to Creatinine Ratio (UACR) From Baseline to Week 12",null,"Frame: From baseline (Day 1) until Week 12 (Day 85)",[14,17,20,23,25,27],{"measure":15,"description":11,"timeFrame":16},"Proportion of participants achieving ≥20%, ≥30%, and ≥40% reduction in UACR from baseline at week 12","From baseline (Day 1) until Week 12 (Day 85)",{"measure":18,"description":11,"timeFrame":19},"Change in Urine Protein\u002FCreatinine Ratio (UPCR) From Baseline at Each Visit","From baseline (Day 1) at each visit",{"measure":21,"description":11,"timeFrame":22},"Change in 24 hour Urinary Protein Excretion From Baseline at Each Visit","From baseline (Day 1) at Each Visit",{"measure":24,"description":11,"timeFrame":22},"Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Each Visit",{"measure":26,"description":11,"timeFrame":22},"Change in Office Systolic and Diastolic Blood Pressure From Baseline at Each Visit",{"measure":28,"description":11,"timeFrame":29},"Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)","From screening until Follow-up visit (Day 98)",{"allocation":31,"interventionModel":32,"interventionModelDescription":11,"primaryPurpose":33,"observationalModel":11,"timePerspective":11,"maskingInfo":34},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":35,"maskingDescription":11,"whoMasked":36},"DOUBLE",[37,38],"PARTICIPANT","INVESTIGATOR",[40,45,48,51],{"label":41,"type":42,"description":41,"interventionNames":43},"HS-10390 Dose A","EXPERIMENTAL",[44],"Drug: HS-10390",{"label":46,"type":42,"description":46,"interventionNames":47},"HS-10390 Dose B",[44],{"label":49,"type":42,"description":49,"interventionNames":50},"HS-10390 Dose C",[44],{"label":52,"type":53,"description":54,"interventionNames":55},"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.",[56],"Drug: Irbesartan",[58,62,64,66],{"type":59,"name":60,"description":60,"armGroupLabels":61,"otherNames":11},"DRUG","HS-10390",[41],{"type":59,"name":60,"description":60,"armGroupLabels":63,"otherNames":11},[46],{"type":59,"name":60,"description":60,"armGroupLabels":65,"otherNames":11},[49],{"type":59,"name":52,"description":67,"armGroupLabels":68,"otherNames":11},"Target dose of 300 mg daily",[52],[70],{"name":71,"role":72,"phone":73,"phoneExt":11,"email":74},"Wei Chen Professor, MD","CONTACT","13924150966","Emailwchen66@qq.com",[76],{"facility":77,"status":11,"city":78,"state":79,"zip":11,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"The First Affiliated Hospital,Sun Yat-sen University","Guangzhou","Guangdong","China","CN",{"type":83,"coordinates":84},"Point",[85,86],113.25,23.11667,{"lat":86,"lon":85},[89],{"name":90,"role":72,"phone":73,"phoneExt":11,"email":74},"Wei Chen WC archiater, Doctor",{"type":92,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":103,"type":104},182,"ESTIMATED","INTERVENTIONAL",[107],"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",[110],"Chronic Kidney Disease",[112],"chronic kidney disease","NOT_YET_RECRUITING","2026-04-21",{"date":116,"type":117},"2026-04-28","ACTUAL",{"date":119,"type":104},"2026-05-21",{"date":121,"type":104},"2028-12-31",{"name":5,"class":6},1]