[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622837":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":52,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":25,"overallStatus":80,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"The Children's Hospital of Zhejiang University School of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Two doses group","EXPERIMENTAL","2 doses of 375mg\u002Fm2 BSA ripertamab at 1-week intervals( within ±1days).",[13],"Drug: ripertamab",{"label":15,"type":16,"description":17,"interventionNames":18},"One dose group","ACTIVE_COMPARATOR","1 dose of 375mg\u002Fm2 BSA ripertamab.",[13],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","ripertamab","2 doses of 375mg\u002Fm2 BSA ripertamab at 1-week intervals( within ±1days). At the meantime, prednisone is administered at a dose of 1.5 mg\u002Fkg\u002Fd (maximum 40 mg) on alternate days or at the dose being used every alternate day before randomization. After 2 weeks, the dose is reduced by 0.25 mg\u002Fkg every 2 weeks, and the drug is discontinued at 3 months.",[9],null,{"type":21,"name":22,"description":27,"armGroupLabels":28,"otherNames":25},"1 dose of 375mg\u002Fm2 BSA ripertamab. At the meantime, prednisone is administered at a dose of 1.5 mg\u002Fkg\u002Fd (maximum 40 mg) on alternate days or at the dose being used every alternate day before randomization. After 2 weeks, the dose is reduced by 0.25 mg\u002Fkg every 2 weeks, and the drug is discontinued at 3 months.",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Jianhua Mao, MD","CONTACT","13516819071","maojh88@zju.edu.cn",{"name":36,"role":32,"phone":37,"phoneExt":25,"email":38},"Xuan Gang, MD","15168358586","gangxuan90@163.com",[40],{"facility":41,"status":25,"city":42,"state":43,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":25},"Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province 310052","Hangzhou","Zhejiang","China","CN",{"type":47,"coordinates":48},"Point",[49,50],120.16142,30.29365,{"lat":50,"lon":49},{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Mao Jianhua","Professor",[57],{"name":58,"class":59},"Sinocelltech Ltd.","INDUSTRY","100622837","study-of-ripertamab-in-children-with-frequent-relapses-or-steroid-dependent-nephrotic-syndrome-100622837",false,"NCT07388810","Study of Ripertamab in Children With Frequent Relapses or Steroid-Dependent Nephrotic Syndrome","Study of Different Doses of Ripertamab in Children With Frequent Relapses or Steroid-Dependent Nephrotic Syndrome：An Open-label Randomized Controlled Trial","Inclusion Criteria:\n\n1. 16 years old and above with FRNS\u002FSDNS\n2. Before enrollment, achieved complete remission (urine protein\u002Fcreatinine ratio (morning urine or 24-hour urine) ≤ 20mg\u002Fmmol (0.2mg\u002Fmg) or \\\u003C 100mg\u002Fm2\u002Fd, or test strip result negative or trace)\n3. Within 2 months before enrollment, did not use levamisole, alkylating agents such as cyclophosphamide, calcineurin inhibitors such as cyclophosphamide and cyclosporine, or mycophenolate mofetil. Within 6 months before enrollment, did not use other CD20 monoclonal antibodies (such as ofatumumab, otuzumab, etc., excluding rituximab)\n4. Glomerular filtration rate (eGFR) \\> 60ml\u002Fmin\u002F1.73m2\n5. The patient or their guardian agrees to participate in this clinical trial and signs the informed consent form, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the study\n\nExclusion Criteria:\n\n1. Known causes (such as systemic lupus erythematosus, IgA nephropathy, other secondary nephrotic syndromes, amyloidosis, malignant tumors, etc.)\n2. Known active chronic infections, including tuberculosis, HIV, HBV, HCV, etc.\n3. Severe leukopenia (white blood cells \\\u003C 3.0×109\u002FL), severe anemia (hemoglobin \\\u003C 8.9 g\u002Fdl), thrombocytopenia (platelets \\\u003C 100×109\u002FL), or liver dysfunction (alanine aminotransferase\u002Faspartate aminotransferase \\> 2 times the upper limit of normal)\n4. Received live vaccines within 1 month prior to screening\n5. Currently participating in other drug clinical trials\n6. Other conditions that the investigator deems make the patient unsuitable for this study","ALL","1 Year","16 Years",{"count":71,"type":72},312,"ESTIMATED","INTERVENTIONAL",[75],"NA","This is an open-label randomized controlled trial to evaluate the efficacy and safety of one dose versus two doses of ripertamab in children with frequent relapses or steroid-dependent nephrotic syndrome (FRNS\u002FSDNS).",[78,79],"FRNS\u002FSDNS","Ripertamab","NOT_YET_RECRUITING","2026-01-29",{"date":83,"type":84},"2026-02-05","ACTUAL",{"date":86,"type":72},"2026-02",{"date":88,"type":72},"2028-02",{"name":54,"class":6},1]