[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525720":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":33,"responsibleParty":50,"collaborators":20,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":20,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"The Children's Hospital of Zhejiang University School of Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Telitacicept group","EXPERIMENTAL","Weekly administration (administration time can be within 1 week + 3 days). Body weight and dosage: for subjects with body weight greater than 10kg and less than or equal to 20kg, the dose of Telitacicept is 40mg; for subjects with body weight greater than 20kg and less than or equal to 40kg, the dose of Telitacicept is 80mg; for subjects with body weight greater than 40kg and less than or equal to 60kg, the dose of Telitacicept is 120mg; for subjects with body weight greater than or equal to 60kg, the dose of Telitacicept is 160mg. Treatment duration: 52 weeks.",[13],"Drug: Telitacicept",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Telitacicept","The study duration was 52 weeks, with the experimental group receiving subcutaneous injections of Telitacicept once weekly for a total of 52 weeks.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Jianhua Mao, MD","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","86057186670015","maojh88@zju.edu.cn",{"name":31,"role":27,"phone":20,"phoneExt":20,"email":32},"Chunyue Feng","springmoonfeng@163.com",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Children's Hospital, Zhejiang University School of Medicine","RECRUITING","Hangzhou","Zhejiang","China","CN",{"type":42,"coordinates":43},"Point",[44,45],120.16142,30.29365,{"lat":45,"lon":44},[48],{"name":23,"role":27,"phone":49,"phoneExt":20,"email":29},"13616819071",{"type":24,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Mao Jianhua","Professor","100525720","phase-3-study-of-the-telitacicept-in-pediatric-patients-with-frequently-relapsing-or-steroid-dependent-nephrotic-syndrome-100525720",false,"NCT06125405","Study of the Telitacicept in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome","STERN","Inclusion Criteria:\n\n* Sensitive but frequent relapses or steroids dependence nephrotic syndrome\n* Age: 2 to 18 years old\n* Normal renal function: estimated glomerular filtration rate ≥90ml\u002F min\u002F1.73m2\n* Morning urine protein \\\u003C1+ or urine protein-creatinine ratio \\\u003C0.2g\u002Fg (\\\u003C20 mg\u002F mmol) for 3 consecutive days and above when in enroll\n* No rituximab was used within 6 months, no tacrolimus, mycophenolate mofetil, cyclosporine A, or cyclophosphamide was used within 3 months, no ACTH was used within 3 months prior to the enrollment\n\nExclusion Criteria:\n\n* Family history of nephrotic syndrome, chronic glomerulonephritis or uremia\n* Leukopenia (White Blood Cells ≤ 3.0 \\* 10\\^9 \u002F L)\n* Moderate to severe anemia (hemoglobin \\\u003C9.0 g\u002FdL)\n* Thrombocytopenia (platelet count \\\u003C100\\*10\\^12\u002FL)\n* Positive Hepatitis B virus serological indicators (Hepatitis B surface antigen or \u002F and Hepatitis B virus e antigen or \u002F and Hepatitis B core antibody), Hepatitis C virus-positive or patients with abnormal liver function (2 or more times of alamine aminotransferase or total bilirubin was exceeded the normal value, and continued to rise for 2 weeks)\n* There are chronic active infections such as Epstein-Barrvirus, cytomegalovirus or Mycobacterium tuberculosis, and the usage of steroids and immunosuppressive agents may aggravate the state of an illness\n* Secondary nephrotic syndrome (such as purpuric nephritis, lupus nephritis, etc.)\n* Those who with hematological or endocrine system diseases as well as serious organs illness such as heart, liver or kidney\n* Those who with other autoimmune diseases or primary immunodeficiencies or tumors\n* Those who have participated in other clinical trials within three months prior to the enrollment\n* Those who was not suitable for participating this study judged by investigator","ALL","2 Years","18 Years",{"count":64,"type":65},20,"ESTIMATED","INTERVENTIONAL",[68],"PHASE3","The main objective is to evaluate the effectiveness of telitacicept in pediatric patients with frequently relapsing or steroid dependent nephrotic syndrome within the 52-week follow-up.",[71,17],"Nephrotic Syndrome in Children",[17,73,74],"Frequently Relapsing Nephrotic Syndrome","Steroid Dependent Nephrotic Syndrome","2024-08-20",{"date":77,"type":78},"2024-08-21","ACTUAL",{"date":80,"type":78},"2023-11-28",{"date":82,"type":65},"2027-10-24",{"name":5,"class":6},1]