[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504106":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":33,"locations":39,"responsibleParty":58,"collaborators":32,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":32,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":32,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":41,"whyStopped":32,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Children's Hospital of Chongqing Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Rituximab","EXPERIMENTAL","2 doses of rituximab 375 mg\u002Fm\\^2 (Maximum 500mg\u002Fday)at 6 months intervals",[13],"Drug: Rituximab",{"label":15,"type":16,"description":17,"interventionNames":18},"Mycophenolate Mofetil","ACTIVE_COMPARATOR","MMF 20\\~30mg\u002Fkg\u002Fday，BID",[19],"Drug: Mycophenolate Mofetil",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","2 doses of rituximab 375 mg\u002Fm\\^2(maximum 500mg\u002Fday) at 6 months intervals.\n\nHalf an hour before rituximab infusion: oral acetaminophen 15mg\u002Fkg, oral or intramuscular antihistamine, methylprednisolone 2mg\u002Fkg IV. Trimethoprim-sulfamethoxazole should be administered orally from the initiation of rituximab therapy until peripheral-blood B cell recovery to prevent pneumocystis infection.",[9],[26],"Rituximab Injection",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Mycophenolate Mofetil 20-30 mg\u002Fkg\u002Fday BID,then adjust the dosage of drugs(maximum 2g\u002Fday) to maintian the concentration for MPA-AUC is 30-50μg.h\u002Fml. Total duration:1year.\n\nSteroids dose:1.5mg\u002Fkg(maximum 40mg) qod for 2 weeks and gradually taper by 0.3 mg\u002Fkg every 2 weeks",[15],[31],"Mycophenolate Mofetil Dispersible tablets",null,[34],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Yang Haiping, Doctor","CONTACT","8618983703661","oyhp@hospital.cqmu.edu.cn",[40],{"facility":5,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Chongqing","Chongqing Municipality","400014","China","CN",{"type":48,"coordinates":49},"Point",[50,51],106.55771,29.56026,{"lat":51,"lon":50},[54],{"name":55,"role":36,"phone":56,"phoneExt":32,"email":57},"Li Qiu, Doctor","8613708353809","liqiu809@hospital.cqmu.edu.cn",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Haiping Yang","Associate Director of Nephrology","100504106","phase-2-efficacy-and-safety-of-rituximab-versus-mycophenolate-mofetil-in-children-with-steroid-dependent-nephrotic-syndrome-100504106",false,"NCT05843968","Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil in Children With Steroid-dependent Nephrotic Syndrome","Rituximab Versus Mycophenolate Mofetil in Children With Steriod-dependent Nephrotic Syndrome: A Single-center, Randomized Controlled Trial","Inclusion Criteria:\n\n* Children with a definite diagnosis of SDNS are included in the study during relapse treatment.\n* Age 3-16 years.\n* Steroid dependent dose≤0.3mg\u002Fkg\u002Fday.\n* Cumulative steroid use for ≥6 months.\n* Ability to swallow tablet.\n* Guardians understand the characteristics and personal consequences of clinical trial.\n* Guardians willing to give informed written consent.\n\nExclusion Criteria:\n\n* Diagnosis of secondary NS, such as secondary to lupus nephritis, hepatitis B-related nephritis, purpura nephritis, etc.\n* Anti-neutrophil cytoplasmic antibodies(ANCA) positive or complement C3 level decreased.\n* Diagnosis of hereditary nephrotic syndrome.\n* Full dose of prednisone (2mg\u002Fkg\u002Fday, maximum 60mg) are used for 14 days after relapse and urine protein don't turn negative.\n* Estimated glomerular filtration rate (eGFR) \\\u003C90mL\u002Fmin per 1.73m\\^2 at study entry.\n* Those who with a known allergy to Mycophenolate Mofetil and their excipients or to Rituximab and its excipients.\n* Those who refuse to participate in the trial.\n* Those who participate other clinical trials.\n* Those who with positive HBV serological markers (HBsAg or\u002Fand HBeAg or\u002Fand HBcAb), HCV positive patients or patients with abnormal liver function (ALT,AST,or bilirubin\\>2 or more times the upper limit of the normal range and persistently elevated for 2 weeks).\n* Severe leukopenia (white blood cells\\\u003C3.0×10\\^9), severe anemia (hemoglobin\\\u003C90g\u002Fl), and thrombocytopenia (platelets\\\u003C100×10\\^9) at study entry.\n* History of pancreatitis or definite gastrointestinal ulcers and\u002For gastrointestinal bleeding within 6 months.\n* Those who with congenital or acquired immune deficiency, or with active tuberculosis, active CMV and other infections.\n* Those who with other serious physical or mental illnesses.\n* History of malignant tumor within 5 years.\n* Those who with congenital heart disease, arrhythmia, heart failure and other serious cardiovascular diseases.\n* Those who with serious infections requiring intravenous antibiotics.","ALL","3 Years","16 Years",{"count":73,"type":74},46,"ESTIMATED","INTERVENTIONAL",[77],"PHASE2","The goal of this clinical trial is to evaluate the efficacy and safety of rituximab(RTX) and mycophenolate mofetile(MMF) in the treatment of children with low-dose steroid-dependent nephrotic syndrome(SDNS).",[80],"Nephrotic Syndrome in Children",[82,9,15],"Nephrotic Syndrome","2024-04-18",{"date":85,"type":86},"2024-04-19","ACTUAL",{"date":88,"type":86},"2023-01-29",{"date":90,"type":74},"2026-07-01",{"name":5,"class":6},1]