[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599655":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":44,"collaborators":19,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":19,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":19,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":19,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"The Children's Hospital of Zhejiang University School of Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SG301 Subcutaneous injection","EXPERIMENTAL","full - dose prednisone (60 mg\u002Fm²\u002Fday, up to 80 mg) for remission induction. After 3 days of negative urine protein, start SG301 Subcutaneous injection with steroid tapering. Taper prednisolone to 60 mg\u002Fm² (max 80 mg) every other day, reducing by 1\u002F6 every 2 weeks, and stop after 3 months.",[13],"Drug: SG301 Subcutaneous injection",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Subcutaneous injection every weeks (QW\\*6),subsequently, administer it once every two weeks for a total of three times (Q2W\\*3). The total number of doses is nine.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Yanyan Jin, Doctor","CONTACT","+86 19357612502","jinyanyanzj@163.com",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Children's Hospital, Zhejiang University School of Medicine","RECRUITING","Hangzhou","Zhejiang","310052","China","CN",{"type":36,"coordinates":37},"Point",[38,39],120.16142,30.29365,{"lat":39,"lon":38},[42],{"name":43,"role":23,"phone":19,"phoneExt":19,"email":19},"Jianhua Mao, Docter",{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"SPONSOR_INVESTIGATOR","Mao Jianhua","Professor","100599655","phase-2-a-study-of-anti-cd38-monoclonal-antibody-sg301-subcutaneous-injection-in-children-with-nephrotic-syndrome-with-frequent-relapses-or-steroid-dependence-100599655",false,"NCT07087314","A Study of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children With Nephrotic Syndrome With Frequent Relapses or Steroid Dependence","A Clinical Study to Evaluate the Initial Efficacy and Safety of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children With Frequent Relapses or Steroid-Dependent Nephrotic Syndrome","Inclusion Criteria:\n\n1. Aged 6 - 18 years.\n2. Steroid-sensitive nephrotic syndrome with frequent relapses (FRNS) or steroid dependence (SDNS).\n3. Normal renal function: eGFR≥90 ml\u002Fmin\u002F1.73m².\n4. After steroid treatment, morning urine protein\\\u003C1 + or urine protein\u002Fcreatinine\\\u003C0.2 g\u002Fg (\\\u003C20 mg\u002Fmmol) for ≥3 consecutive days.\n5. Within 7 days before enrollment, blood tests (without growth factors or transfusions) must meet: hemoglobin\\>80 g\u002FL; platelets\\>75×10⁹\u002FL; neutrophils\\>1.5×10⁹\u002FL.\n6. Prothrombin time\u002FINR≤1.5×ULN, unless due to anticoagulation.\n7. No Tacrolimus, cyclosporine A, mycophenolate mofetil, belimumab, levamisole, azathioprine, or cyclophosphamide in prior 2 months; no rituximab or obinutuzumab in prior 6 months.\n\nExclusion Criteria:\n\n1. Family history of nephrotic syndrome, chronic glomerulonephritis, or uremia.\n2. Alanine aminotransferase \\>2×ULN or total bilirubin\\>2×ULN with a sustained increase for 2 weeks.\n3. HBsAg or HBcAb positive with Hepatitis B virus DNA above the lower limit of normal; Hepatitis C virus antibody - positive with Hepatitis C virus RNA positive; HIV antibody - positive.\n4. Chronic active infections (e.g., Epstein-Barr Virus, Cytomegalovirus, tuberculosis) that may worsen with steroids\u002F immunosuppressants.\n5. Acute active infection (excluding onychomycosis) requiring systemic antibiotics\u002Fantivirals.\n6. Secondary nephrotic syndrome (e.g.,immunoglobulin A - associated, lupus nephritis); steroid - resistant nephrotic syndrome (SRNS).\n7. Other autoimmune diseases, primary immunodeficiency, or malignancy.\n8. Prior anti - cluster of differentiation 38 (CD38) treatment.\n9. Live\u002Fattenuated vaccine receipt or major surgery (non - diagnostic) within 4 weeks before first dose.","ALL","6 Years","18 Years",{"count":59,"type":60},30,"ESTIMATED","INTERVENTIONAL",[63],"PHASE2","This is an open - label study to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of SG301 Subcutaneous injection in children with frequently relapsing or steroid - dependent nephrotic syndrome.",[66],"Nephrotic Syndrome in Children","2026-02-26",{"date":69,"type":70},"2026-02-27","ACTUAL",{"date":72,"type":70},"2025-08-25",{"date":74,"type":60},"2029-07-09",{"name":46,"class":6},1]