[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564945":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":32,"locations":38,"responsibleParty":50,"collaborators":28,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":28,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":28,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":73,"whyStopped":28,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Hansoh BioMedical R&D Company","INDUSTRY",[8,13,16],{"label":9,"type":10,"description":9,"interventionNames":11},"HS-10390; high dose","EXPERIMENTAL",[12],"Drug: HS-10390",{"label":14,"type":10,"description":14,"interventionNames":15},"HS-10390; low dose",[12],{"label":17,"type":18,"description":19,"interventionNames":20},"irbesartan","ACTIVE_COMPARATOR","Irbesartan will be administered daily as a 150-mg oral tablet. For patients who tolerate the initial dose of 150 mg after 2 weeks will increase their dose to 300 mg",[21],"Drug: Irbesartan",[23,29],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","HS-10390","HS-10390 will be administered daily",[9,14],null,{"type":24,"name":30,"description":19,"armGroupLabels":31,"otherNames":28},"Irbesartan",[17],[33],{"name":34,"role":35,"phone":36,"phoneExt":28,"email":37},"jicheng Lv, PhD","CONTACT","+8613161753111","chenglv@263.net",[39],{"facility":40,"status":28,"city":41,"state":28,"zip":28,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":28},"Peking University First Hospital","Beijing","China","CN",{"type":45,"coordinates":46},"Point",[47,48],116.39723,39.9075,{"lat":48,"lon":47},{"type":51,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100564945","phase-2-a-study-of-the-effect-and-safety-of-hs-10390-in-the-treatment-of-patients-with-primary-iga-nephropathy-100564945",false,"NCT06635772","A Study of the Effect and Safety of HS-10390 in the Treatment of Patients with Primary IgA Nephropathy","A Randomized, Multicenter, Open-label, Active-control Study of the Efficacy and Safety of HS-10390 for the Treatment of Immunoglobulin a Nephropathy","Inclusion Criteria:\n\n* Male or female, between 18 and 65 years age.\n* Biopsy-proven primary IgA nephropathy.\n* Currently on stable dose of ACEI and\u002For ARB therapy, for at least 12 weeks prior to screening (the patient's maximum tolerated dose and is at least one-half of the maximum labeled dose).\n* Average 24-hour urine total protein ≥ 0.75 g\u002F24 h at screening.\n* Estimated GFR (using the CKD-EPI 2009) ≥ 30 mL\u002Fmin per 1.73 m\\^2 at screening.\n* Systolic BP between 100 and 150 mmHg and diastolic BP between 60 and 100 mmHg.\n\nExclusion Criteria:\n\n* IgA nephropathy secondary to another condition\n* IgA nephropathy with rapid decline of renal function; Kidney pathology indicated that more than 50% of the glomerulus had large crescent body formation, which may affect the study results; Tubule atrophy - interstitial fibrosis of more than 50%;\n* Chronic kidney disease (CKD) in addition to IgAN\n* Patients treated with any systemic non-biologic immunosuppressive drugs (including systemic corticosteroids) within 12 weeks prior to randomizing；\n* Require any prohibited medications prior to randomizing;\n* Exposure to an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening\n* History of organ transplantation, with exception of corneal transplants\n* Platelet\\\u003C 100×109\u002FL or hemoglobin value \\\u003C 90 g\u002FL) or Hematocrit value \\\u003C 27% (0.27 V\u002FV) at Screening\n* Elevations of transaminases (ALT and\u002For AST) \\>2 times upper limit of normal or total bilirubin and\u002For direct bilirubin exceeding 1.5 times the upper limit of normal (ULN) at screening\n* Potassium \\>5.5 mmol\u002FL at Screening","ALL","18 Years","65 Years",{"count":63,"type":64},90,"ESTIMATED","INTERVENTIONAL",[67],"PHASE2","This study will evaluate the efficacy and safety of HS-10390 in subjects with primary IgA nephropathy, and explore the optimal dose for the treatment.",[70],"Immunoglobulin a Nephropathy",[72],"Immunoglobulin A Nephropathy","NOT_YET_RECRUITING","2024-10-08",{"date":76,"type":77},"2024-10-10","ACTUAL",{"date":79,"type":64},"2024-11",{"date":81,"type":64},"2026-04-30",{"name":5,"class":6},1]