[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579907":3},{"organization":4,"armGroups":7,"interventions":37,"overallOfficials":48,"centralContacts":53,"locations":59,"responsibleParty":72,"collaborators":11,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":11,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":11,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":11,"overallStatus":93,"whyStopped":11,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Keymed Biosciences Co.Ltd","INDUSTRY",[8,14,17,20,23,28,31,34],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A: CM313 low dose","EXPERIMENTAL",null,[13],"Biological: CM313",{"label":15,"type":10,"description":11,"interventionNames":16},"Part A: CM313 high dose",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Part B: CM313 low dose with low frequency",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"Part B: CM313 low dose with high frequency",[13],{"label":24,"type":25,"description":11,"interventionNames":26},"Part B: Placebo matching the volume of low dose CM313","PLACEBO_COMPARATOR",[27],"Drug: Placebo",{"label":29,"type":10,"description":11,"interventionNames":30},"Part B: CM313 high dose with low frequency",[13],{"label":32,"type":10,"description":11,"interventionNames":33},"Part B: CM313 high dose with high frequency",[13],{"label":35,"type":25,"description":11,"interventionNames":36},"Part B: Placebo matching the volume of high dose CM313",[27],[38,43],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":11},"BIOLOGICAL","CM313","CM313(SC) injection",[15,9,32,29,21,18],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":11},"DRUG","Placebo","Matched placebo",[35,24],[49],{"name":50,"affiliation":51,"role":52},"Jicheng Lv","Peking University Frist Hospital","PRINCIPAL_INVESTIGATOR",[54],{"name":55,"role":56,"phone":57,"phoneExt":11,"email":58},"Qian Jia","CONTACT","028-88610620","qianjia@keymedbio.com",[60],{"facility":61,"status":11,"city":62,"state":63,"zip":11,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":11},"Peking University First Hospital","Beijing","Beijing Municipality","China","CN",{"type":67,"coordinates":68},"Point",[69,70],116.39723,39.9075,{"lat":70,"lon":69},{"type":73,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100579907","phase-2-study-of-cm313-in-subject-with-iga-nephropathy-100579907",false,"NCT06830395","Study of CM313 in Subject With IgA Nephropathy","A Phase II Clinical Study to Evaluate the Safety and Efficacy of CM313 (SC) Injection in Subjects With Primary IgA Nephropathy","Inclusion Criteria:\n\n* Able to comprehend the research study and voluntarily signing the informed consent form (ICF).\n* Renal biopsy report supporting diagnosis of primary IgAN within 8 years prior to the screening visit.\n* Estimated Glomerular Filtration Rate (eGFR) (using the Chronic Kidney Disease Epidemiology Collaboration formula) ≥ 30 mL\u002Fmin\u002F1.73 (m\\*m) at screening and baseline.\n* Prior to the baseline visit, all subjects must have received standard care treatment, including good blood pressure control and a stable treatment of a maximum recommended or maximum tolerated dose of angiotensin-converting enzyme inhibitors(ACEI) or Angiotensin receptor blocker(ARB) for at least 12 weeks.\n* 24-hour urinary protein-to-creatinine ratio (24h-UPCR) ≥ 0.75 g\u002Fg or 24-hour urinary protein excretion (24h-UPE) ≥ 1 g\u002Fd during the screening and baseline periods.\n\nExclusion Criteria:\n\n* Secondary IgAN judged by the investigator: Secondary IgAN may be associated with Henoch-Schonlein purpura, hepatic cirrhosis, coeliac disease, human immunodeficiency virus (HIV) infection, dermatitis herpetiformis, seronegative arthritis, small cell carcinoma, lymphoma, disseminated tuberculosis, obliterative bronchiolitis, inflammatory bowel disease, familial Mediterranean fever, etc.\n* Known allergy to monoclonal antibody drugs or to the excipients of CM313.\n* Presence of rapidly progressive glomerulonephritis (RPGN), defined as 50% decline in eGFR within 3 months prior to randomization and\u002For crescent formation in more than 50% of glomeruli in a renal pathological specimen.\n* Confirmed acute kidney injury (AKI) within 4 weeks prior to randomization.\n* Vaccination of any live vaccine within 30 days prior to dosing or planned vaccination during the study period.\n* History of transplantation (any solid organ transplant, including renal transplant, bone marrow transplant, etc.) or plan to undergo renal transplantation during the study.\n* History of severe recurrent or chronic infection.\n* Malignant tumor within 5 years prior to screening (except for completely cured cervix carcinoma in situ and non-skin squamous cell carcinoma metastatic or basal cell carcinoma).","ALL","18 Years","75 Years",{"count":85,"type":86},106,"ESTIMATED","INTERVENTIONAL",[89],"PHASE2","This study is divided into two parts (Part A and Part B). This study aims to evaluate the safety and efficacy of CM313 in subjects with primary Immunoglobulin A nephropathy(IgAN), while also observing its Pharmacokinetics(PK) characteristics, Pharmacokinetics(PD) effects, and immunogenicity.",[92],"IgA Nephropathy","NOT_YET_RECRUITING","2025-09-15",{"date":96,"type":97},"2025-09-19","ACTUAL",{"date":99,"type":86},"2025-09",{"date":101,"type":86},"2028-08",{"name":5,"class":6},1]