[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620198":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":33,"centralContacts":37,"locations":10,"responsibleParty":43,"collaborators":10,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":10,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":60,"studyType":61,"phases":10,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":70,"whyStopped":10,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":10},{"fullName":5,"class":6},"The Children's Hospital of Zhejiang University School of Medicine","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Glucocorticoids group",null,"Throughout the treatment period, the participants were administered glucocorticoids but did not receive any immunosuppressants or biologic therapies.",[13,14],"Device: Collect clinical data from the patients.","Drug: This study exclusively prospectively collected clinical data from the patients and did not involve any therapeutic interventions",{"label":16,"type":10,"description":17,"interventionNames":18},"Telitacicept group","Throughout the treatment period, the participants were administered telitacicept but did not receive any immunosuppressants, glucocorticoids and other biologic therapies.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Glucocorticoids combined Telitacicept group","Throughout the treatment period, the participants were administered both glucocorticoids and telitacicept but did not receive any immunosuppressants or other biologic therapies.",[13,14],[24,29],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"DEVICE","Collect clinical data from the patients.","This study exclusively prospectively collected clinical data from the patients and did not involve any therapeutic interventions.",[20,9,16],{"type":30,"name":31,"description":31,"armGroupLabels":32,"otherNames":10},"DRUG","This study exclusively prospectively collected clinical data from the patients and did not involve any therapeutic interventions",[20,9,16],[34],{"name":35,"affiliation":5,"role":36},"Jianhua Mao","STUDY_CHAIR",[38],{"name":39,"role":40,"phone":41,"phoneExt":10,"email":42},"Aiqin Sheng","CONTACT","+8615715734421","shengaiqin99@163.com",{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Mao Jianhua","Director, Head of Nephrology, Principal Investigator, Clinical Professor","100620198","telitacicept-in-the-treatment-of-pediatric-iga-vasculitis-associated-nephritis-100620198",false,"NCT07354503","Telitacicept in the Treatment of Pediatric IgA Vasculitis-Associated Nephritis","The Efficacy and Safety of Telitacicept in the Treatment of Pediatric IgA Vasculitis-Associated Nephritis: A Multicenter Clinical Study","Inclusion Criteria:\n\n1. Age 3-17 years;\n2. Patients diagnosed with IgA vasculitis nephritis (IgAVN) based on clinical manifestations and renal pathological diagnosis;\n3. Urinary protein quantification requirements: urinary protein\u002Fcreatinine ratio (UPCR) of ≥1 mg\u002Fmg (100 mg\u002Fmmol);\n4. Estimated glomerular filtration rate (eGFR) calculated using the modified Schwartz formula of ≥60 mL\u002Fmin\u002F1.73 m².\n5. Renal biopsy is optional (if a renal biopsy is performed, cases classified as International Society of Nephropathology (ISKDC) grade ≥IV must be excluded).\n\nExclusion Criteria:\n\n1. Patients with congenital or acquired immunodeficiency, or those with concurrent tuberculosis, active cytomegalovirus (CMV), Epstein-Barr virus(EBV), hepatitis B, hepatitis C, Human Immunodeficiency Virus(HIV) infection, deep fungal infections, or other active infections;\n2. Patients exhibiting the following abnormal laboratory indicators at the time of initial diagnosis: moderate to severe neutropenia (≤1000\u002FμL); moderate to severe anemia (hemoglobin \\\u003C9.0 g\u002FdL); thrombocytopenia (platelet count \\\u003C100×10\\^12\u002FL); or abnormal liver function (Alanine Aminotransferase(ALT), Aspartate Aminotransferase(AST), or bilirubin exceeding 2.5 times the upper limit of normal and persistently elevated for 2 weeks);\n3. Patients with a history of tumors or severe cardiovascular, digestive system, hematological, endocrine, or other systemic diseases;\n4. Patients with concurrent other urinary system diseases (such as hereditary kidney diseases, etc.);\n5. Subjects with severe osteoporosis requiring treatment;\n6. Subjects diagnosed with uncontrolled mental illness or intellectual disabilities;\n7. Subjects who have received B-cell targeted therapy within the last 6 months;\n8. History of major organ transplant or hematopoietic stem cell\u002Fcell\u002Fbone marrow or kidney transplant;\n9. Vaccination with live attenuated vaccines within 1 month prior to treatment;\n10. Use of various traditional Chinese medicines for treating kidney diseases during the treatment period (patients who have previously used traditional Chinese medicine can be included, but are strictly prohibited from using it after receiving treatment according to the protocol);\n11. Incomplete clinical data.","ALL","3 Years","17 Years",{"count":58,"type":59},300,"ESTIMATED","48 Weeks","OBSERVATIONAL","To further evaluate the efficacy and safety of Telitacicept in the treatment of pediatric IgA vasculitis nephritis (IgAVN) within real-world settings, this study employs a multicenter, retrospective and prospective observational research design. It aims to compare the efficacy of Telitacicept with that of glucocorticoids, thereby providing clinicians with a reference for the rational and standardized application of Telitacicept.",[64,65],"IgAVN","IgA Vasculitis",[67,68,69],"IgAV nephritis","Telitacicept","Children","NOT_YET_RECRUITING","2026-01-15",{"date":73,"type":74},"2026-01-21","ACTUAL",{"date":76,"type":59},"2026-01-01",{"date":78,"type":59},"2028-06-30",{"name":5,"class":6}]