[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651835":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":41,"locations":48,"responsibleParty":120,"collaborators":122,"id":131,"slug":132,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":46,"eligibilityCriteria":137,"healthyVolunteers":133,"sex":138,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":46,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":152,"whyStopped":46,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"Children's Hospital of Fudan University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Zuberitamab + Standard corticosteroid treatment","EXPERIMENTAL","Zuberitamab plus standard corticosteroid treatment: Zuberitamab 375 mg\u002Fm2 (max 500 mg) as a single IV dose after remission. Premedication 30 min prior includes oral antipyretic and antihistamine and IV methylprednisolone 1.6 mg\u002Fkg (max 48 mg); oral steroid withheld on infusion day. Standard corticosteroid treatment consists of oral prednisone\u002Fprednisolone per protocol taper. TMP-SMZ prophylaxis (TMP 3 mg\u002Fkg on alternate days, max SMZ 960 mg) is administered until CD19 recovery. Relapse is managed per protocol with corticosteroid re-induction and possible repeat zuberitamab after remission. Permitted and prohibited concomitant medications are the same as in the comparator arm.",[13,14],"Biological: Zuberitamab","Drug: standard corticosteroid treatment",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard corticosteroid treatment Only","ACTIVE_COMPARATOR","Standard corticosteroid treatment: oral prednisone\u002Fprednisolone 2 mg\u002Fkg\u002Fday (max 60 mg) for 6 weeks, followed by 1.5 mg\u002Fkg (max 40 mg) on alternate days for 6 weeks, then discontinue. No zuberitamab, TMP-SMZ prophylaxis, or infusion premedication is given during initial treatment. Relapse is managed per protocol with corticosteroid re-induction; participants may receive zuberitamab after remission is re-achieved according to predefined criteria. Permitted concomitant medications include antihypertensives, calcium supplementation, anti-infective agents, antihistamines, anticoagulants, IVIG, hepatoprotective agents, glucose-lowering medications, and ophthalmic treatments. Prohibited therapies include other immunosuppressants (rituximab, CNIs, MMF, cyclophosphamide, plasma exchange) and Chinese herbal medicines for nephrotic syndrome (e.g., Huangkui, Huaiqihuang, Tripterygium). Live vaccines are prohibited during B-cell depletion.",[14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Zuberitamab","Zuberitamab is administered as a single intravenous infusion at a dose of 375 mg\u002Fm² (maximum 500 mg) following achievement of steroid-sensitive remission.\n\nTo reduce the risk of infusion-related reactions, premedication is administered approximately 30 minutes before infusion and may include:\n\n* Acetaminophen or ibuprofen;\n* Cetirizine, cyproheptadine, loratadine, or equivalent antihistamines;\n* Intravenous methylprednisolone 1.6 mg\u002Fkg (maximum 48 mg).\n\nParticipants receiving zuberitamab also receive prophylactic trimethoprim-sulfamethoxazole (TMP 3 mg\u002Fkg every other day; maximum SMZ dose 960 mg every other day) until B-cell recovery.\n\nInfusion-related reactions are managed according to protocol-defined procedures, including infusion rate reduction, temporary interruption, permanent discontinuation when clinically indicated, and appropriate supportive therapy.",[9],[27],"Zuberitamab (BioRay Biopharmaceutical Co., Ltd.)",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","standard corticosteroid treatment","standard corticosteroid treatment administered orally to treat steroid-sensitive nephrotic syndrome: 6 weeks at 2 mg\u002Fkg (max 60 mg\u002Fday), then alternate day steroid 1.5 mg\u002Fkg (max 40 mg on alternate days) for 6 weeks.",[16,9],[34],"prednisolone\u002Fprednisone",[36,39],{"name":37,"affiliation":5,"role":38},"Hong Xu","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":5,"role":38},"Qian Shen",[42],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Jialu Liu","CONTACT","8602164932827",null,"jialuliu10@fudan.edu.cn",[49,62,70,81,86,91,96,104,112],{"facility":5,"status":46,"city":50,"state":51,"zip":46,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Shanghai","Shanghai Municipality","China","CN",{"type":55,"coordinates":56},"Point",[57,58],121.45806,31.22222,{"lat":58,"lon":57},[61],{"name":37,"role":44,"phone":46,"phoneExt":46,"email":46},{"facility":63,"status":46,"city":64,"state":46,"zip":46,"country":52,"countryCode":53,"cosmosGeoPoint":65,"geoPoint":69,"contacts":46},"Second Xiangya Hospital of Central South University","Changsha",{"type":55,"coordinates":66},[67,68],112.97087,28.19874,{"lat":68,"lon":67},{"facility":71,"status":46,"city":72,"state":46,"zip":46,"country":52,"countryCode":53,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Guiyang Maternal and Child Health Care Hospital","Guiyang",{"type":55,"coordinates":74},[75,76],106.71667,26.58333,{"lat":76,"lon":75},[79],{"name":80,"role":44,"phone":46,"phoneExt":46,"email":46},"Yuhong Li",{"facility":82,"status":46,"city":50,"state":46,"zip":46,"country":52,"countryCode":53,"cosmosGeoPoint":83,"geoPoint":85,"contacts":46},"Shanghai Children's Hospital",{"type":55,"coordinates":84},[57,58],{"lat":58,"lon":57},{"facility":87,"status":46,"city":50,"state":46,"zip":46,"country":52,"countryCode":53,"cosmosGeoPoint":88,"geoPoint":90,"contacts":46},"Shanghai Children's Medical Center",{"type":55,"coordinates":89},[57,58],{"lat":58,"lon":57},{"facility":92,"status":46,"city":50,"state":46,"zip":46,"country":52,"countryCode":53,"cosmosGeoPoint":93,"geoPoint":95,"contacts":46},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine",{"type":55,"coordinates":94},[57,58],{"lat":58,"lon":57},{"facility":97,"status":46,"city":98,"state":46,"zip":46,"country":52,"countryCode":53,"cosmosGeoPoint":99,"geoPoint":103,"contacts":46},"Wuhan Children's Hospital","Wuhan",{"type":55,"coordinates":100},[101,102],114.26667,30.58333,{"lat":102,"lon":101},{"facility":105,"status":46,"city":106,"state":46,"zip":46,"country":52,"countryCode":53,"cosmosGeoPoint":107,"geoPoint":111,"contacts":46},"Wuxi Women's & Children's Hospital","Wuxi",{"type":55,"coordinates":108},[109,110],120.28857,31.56887,{"lat":110,"lon":109},{"facility":113,"status":46,"city":114,"state":46,"zip":46,"country":52,"countryCode":53,"cosmosGeoPoint":115,"geoPoint":119,"contacts":46},"Xiamen Maternity & Child Care Hospital","Xiamen",{"type":55,"coordinates":116},[117,118],118.08187,24.47979,{"lat":118,"lon":117},{"type":121,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR",[123,124,125,126,127,128,129,130],{"name":71,"class":6},{"name":97,"class":6},{"name":87,"class":6},{"name":92,"class":6},{"name":82,"class":6},{"name":105,"class":6},{"name":113,"class":6},{"name":63,"class":6},"100651835","phase-3-zuberitamab-in-the-first-episode-of-paediatric-nephrotic-syndrome-100651835",false,"NCT07765914","Zuberitamab in the First Episode of Paediatric Nephrotic Syndrome","Efficacy and Safety of Single-dose Zuberitamab in the Initial Episode of Paediatric Steroid-sensitive Nephrotic Syndrome: A Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n* Newly diagnosed steroid-sensitive nephrotic syndrome (SSNS) according to the 2023 IPNA criteria, who achieved complete remission after steroid induction therapy prior to study entry, defined as UPCR (based on first morning void or 24 h urine sample) \\\u003C= 20 mg\u002Fmmol (0.2 mg\u002Fmg), or negative or trace dipstick on three or more consecutive days.\n* An estimated glomerular filtration rate \\>= 90 mL\u002Fmin\u002F 1.73 m2 at study entry.\n* Peripheral blood CD20+ (detected as CD19+) cells \\>= 1% of total lymphocytes.\n* No use of other immunosuppressants within 3 months prior to study entry, other than steroids for nephrotic syndrome.\n\nExclusion Criteria:\n\n* Known etiology including congenital nephrotic syndrome, IgA nephropathy, Henoch-Schönlein purpura nephritis, lupus nephritis, or other secondary nephrotic syndromes.\n* Patients exhibiting any of the following abnormal clinical laboratory values: leukopenia (white blood cells \\\u003C= 3.0 × 10\\^9\u002FL), absolute neutrophil count \\\u003C 1.5 × 10\\^9\u002FL; moderate to severe anemia (hemoglobin \\\u003C 9.0 g\u002FdL); thrombocytopenia (platelet count \\\u003C 100 × 10\\^12\u002FL); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 2.5 times the upper limit of normal; positive for any autoimmune markers (ANA, ENA, ANCA, etc.) or decreased complement C3 levels.\n* Evidence of the following infections: severe or opportunistic infection within the previous 6 months (active tuberculosis or history of tuberculosis or suspected tuberculosis; chronic active infections such as EBV, CMV; active hepatitis B presentation or history, or hepatitis C or hepatitis B virus carrier; HIV infection; or other active viral infections).\n* Receipt of live vaccine within one month prior to study entry.\n* History of previous use of biological agents.\n* Current examination suggestive of heart failure, severe arrhythmia, angina pectoris (CTCAE Grade 4), or uncontrolled blood pressure.\n* Severe diseases of vital organs such as the brain or liver, or suffering from hematological or endocrine system disorders.\n* Diagnosis of co-existing autoimmune diseases, primary immunodeficiency, or malignancy.\n* History of organ transplantation (excluding cornea and hair transplants).\n* Known allergy to methylprednisolone, Zuberitamab injection active ingredients or any excipients, sulfamethoxazole (or a contraindication to this drug due to G6PD deficiency).\n* Investigator's judgment that the patient is unsuitable for participation in this study (e.g., patient is highly likely to be lost to follow-up or provide false results, such as alcohol dependence or psychiatric illness).","ALL","1 Year","18 Years",{"count":142,"type":143},120,"ESTIMATED","INTERVENTIONAL",[146],"PHASE3","The goal of this clinical trial is to learn whether adding Zuberitamab to standard corticosteroid therapy can help prevent relapse in children and adolescents aged 1 to 18 years with newly diagnosed steroid-sensitive nephrotic syndrome (SSNS). It will also learn about the safety of Zuberitamab.\n\nThe main questions it aims to answer are:\n\n* Does Zuberitamab plus standard corticosteroid therapy prolong the time to first relapse compared with standard corticosteroid therapy alone?\n* What medical problems do participants experience during treatment?\n\nResearchers will compare Zuberitamab plus standard corticosteroid therapy to standard corticosteroid therapy alone to see whether adding Zuberitamab improves disease control.\n\nParticipants will:\n\n* Receive standard corticosteroid treatment for approximately 12 weeks, with or without a single intravenous infusion of Zuberitamab after achieving remission\n* Take preventive antibiotics if they are in the Zuberitamab group\n* Test their urine daily at home using dipsticks and record results in a diary\n* Visit the clinic for regular checkups and blood and urine tests during follow-up for up to 12 months",[149],"Nephrotic Syndrome",[151],"Anti-CD20 Monoclonal Antibody, Randomised Controlled Trial","NOT_YET_RECRUITING","2026-08-11",{"date":155,"type":156},"2026-08-14","ACTUAL",{"date":158,"type":143},"2026-08-20",{"date":160,"type":143},"2028-12-31",{"name":5,"class":6},9]