[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644839":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":11,"centralContacts":49,"locations":11,"responsibleParty":55,"collaborators":11,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":11,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":11,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":11,"overallStatus":76,"whyStopped":11,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":11},{"fullName":5,"class":6},"Nanfang Hospital, Southern Medical University","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Rituximab combining with low-dose mycophenolate mofetil","EXPERIMENTAL",null,[13,14,15,16,17],"Drug: rituximab","Drug: Mycophenolate Mofetil (MMF) Treatment","Drug: ACEI \u002F ARB","Drug: Corticosteroid","Drug: Hydroxychloroquine (HCQ)",{"label":19,"type":20,"description":11,"interventionNames":21},"cyclophosphamide","ACTIVE_COMPARATOR",[22,15,16,17],"Drug: Cyclophosphamide",[24,29,33,37,41,45],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"DRUG","rituximab","Rituximab is given monthly (375m\u002Fm2；maximum 500mg) for 6 doses",[9],{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"Mycophenolate Mofetil (MMF) Treatment","The dose of mycophenolate mofetil is 10 to 15mg\u002Fkg\u002Fd for 6 months.",[9],{"type":25,"name":34,"description":35,"armGroupLabels":36,"otherNames":11},"Cyclophosphamide","The therapy for cyclophosphamide is 750mg\u002Fm2（maximum 1000mg） every month for 6 doses.",[19],{"type":25,"name":38,"description":39,"armGroupLabels":40,"otherNames":11},"ACEI \u002F ARB","ACEI\u002FARB is recommended as the basic therapy for lupus nephritis.",[9,19],{"type":25,"name":42,"description":43,"armGroupLabels":44,"otherNames":11},"Corticosteroid","Corticosteroid is recommended as the basic therapy for lupus nephritis.",[9,19],{"type":25,"name":46,"description":47,"armGroupLabels":48,"otherNames":11},"Hydroxychloroquine (HCQ)","Hydroxychloroquine is recommended as the basic therapy for lupus nephritis.",[9,19],[50],{"name":51,"role":52,"phone":53,"phoneExt":11,"email":54},"Liangzhong Sun","CONTACT","+8613316202736","sunlzh2018@smu.edu.cn",{"type":56,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100644839","rituximab-combining-with-low-dose-mycophenolate-mofetil-on-proliferative-lupus-nephritis-in-children-100644839",false,"NCT07675291","Rituximab Combining With Low-Dose Mycophenolate Mofetil on Proliferative Lupus Nephritis in Children","Efficacy and Safety of Rituximab Combining With Low-Dose Mycophenolate Mofetil in the Induction Therapy of Proliferative Lupus Nephritis in Children","Inclusion Criteria:\n\n1. Children aged 3-18 years old, regardless of sex;\n2. SLE patients who meet the 2019 EULAR\u002FACR SLE criteria or the 2012 SLICC diagnostic criteria;\n3. Diagnosed as lupus nephritis and the classification was consistent with proliferative lupus nephritis (type III or IV, with or without type V);\n4. White blood cell count ≥3.0×10\\^9\u002FL, and lymphocyte count ≥ 0.5× 10\\^9\u002FL and CD20 (or CD19)≥1\u002Ful;\n5. No cyclophosphamide or rituximab induction therapy was used before enrollment;\n6. Informed consent form is signed by the guardian and children over 8 years old;\n7. In the active stage of the disease, the 24-hour urine protein quantification ≥25mg\u002Fkg, or the urine protein\u002Fcreatinine ≥1.0mg\u002Fmg;\n8. Estimated GFR≥60ml\u002Fmin\u002F1.73m\\^2 (improved Swchartz formula).\n\nExclusion Criteria:\n\n1. Patients with lupus encephalopathy;\n2. Estimated GFR\\\u003C60ml\u002Fmin\u002F1.73m\\^2(Swchartz formula);\n3. HBV-antigen positive, HCV or HIV antibody positive;\n4. Severe infection (including chronic hepatitis, EB virus or cytomegalovirus infection) and tuberculosis;\n5. Allergic to the active ingredients or any auxiliary materials in rituximab, mycophenolate mofetil or cyclophosphamide;\n6. Severe heart failure and liver function damage;\n7. Patients who is not suitable to participate in this study judged by the researchers.","ALL","3 Years","18 Years",{"count":68,"type":69},112,"ESTIMATED","INTERVENTIONAL",[72],"NA","The objective of this study is to assess the efficacy and safety of rituximab combining with low-dose mycophenolate mofetil in the induction therapy of proliferative lupus nephritis in children.",[75],"Lupus Nephritis","NOT_YET_RECRUITING","2026-06-29",{"date":79,"type":80},"2026-06-30","ACTUAL",{"date":82,"type":69},"2026-06",{"date":84,"type":69},"2028-12-31",{"name":5,"class":6}]