[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"igavn\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:igavn":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,81],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100594831","phase-3-study-of-ravulizumab-in-pediatric-participants-with-primary-igan-100594831",false,"NCT07024563","Study of Ravulizumab in Pediatric Participants With Primary IgAN","A Phase 3, Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of Ravulizumab in Pediatric Participants (2 to \u003C 18 Years of Age) With Primary Immunoglobulin A Nephropathy (IgAN)","Inclusion Criteria:\n\n* Participant must be 2 to \\\u003C 18 years of age at the time of signing the informed consent or assent.\n* Stable and maximum allowed or tolerated RASI (ACEI and\u002For ARB) dose for ≥ 3 months prior to Screening with no planned change during Screening through Week 106.\n* UPCR ≥ 1.0 g\u002Fg from the mean of 3 first morning voids (FMV) collected within 1 week during the Screening Period\n* Estimated GFR ≥ 30 mL\u002Fmin\u002F1.73 m2 during Screening\n* Meningococcal infection vaccine\n* Haemophilus influenzae type b and Streptococcus pneumoniae vaccine\n* Participants who are receiving SGLT2i, DEARA (eg, sparsentan), MRA, ERA, or GLP-1 agonists must be on a stable and maximum allowed or tolerated dose for ≥ 3 months prior to Screening with no planned change in dose through Week 34.\n* Established diagnosis of primary IgAN diagnosis based on kidney biopsy within 3 years prior to Screening or during the Screening Period\n\nExclusion Criteria:\n\n* Diagnosis of rapidly progressive glomerulonephritis\n* Secondary forms of IgAN not in the context of primary IgAN or IgAV\n* Concomitant clinically significant renal disease other than IgAN or IgAVN\n* Clinical remission of IgAN\u002FIgAVN or clinically significant improvement in proteinuria within the last 6 months.\n* Uncontrolled diabetes mellitus with HbA1c \\> 8.5%\n* History of kidney transplant or planned kidney transplant during the Primary Evaluation Period.\n* History of other solid organ (heart, lung, small bowel, pancreas, or liver) or bone marrow transplant\n* Splenectomy or functional asplenia\n* Participants with nephrotic syndrome receiving albumin infusions or with acute kidney injury requiring dialysis within the last 6 months prior to Screening.\n* Hemolytic uremic syndrome diagnosed any time prior to Screening.\n* Planned urological surgery expected to influence kidney function within the study time frame.\n* Congenital immunodeficiency\n* Active systemic bacterial, viral, or fungal infection within 14 days prior to enrollment\n* Received biologics for the treatment of IgAN or IgAVN within≤ 6 months prior to Screening","ALL","2 Years","18 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The primary objectives of this study are to characterize ravulizumab pharmacokinetics (PK) and pharmacodynamics (PD), and to evaluate safety and efficacy following ravulizumab IV dosing in pediatric participants with IgAN or IgAVN.",[27,28,29,30,31,32],"IgAN","IgAVN","Immunoglobulin A Nephropathy","Immunoglobulin A Vasculitis Associated Nephritis","Henoch-schonlein Purpura Nephritis","IgA Vasculitis",[34,27,28,35,36,37,29,30],"ravulizumab","pediatric","proteinuria","glomerulonephropathy","RECRUITING","2026-03-16",{"date":41,"type":42},"2026-03-17","ACTUAL",{"date":44,"type":42},"2025-06-14",{"date":46,"type":21},"2029-11-27",{"name":48,"class":49},"Alexion Pharmaceuticals, Inc.","INDUSTRY",14,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":62,"studyType":63,"phases":4,"briefSummary":64,"conditions":65,"keywords":66,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":4},"100620198","telitacicept-in-the-treatment-of-pediatric-iga-vasculitis-associated-nephritis-100620198","NCT07354503","Telitacicept in the Treatment of Pediatric IgA Vasculitis-Associated Nephritis","The Efficacy and Safety of Telitacicept in the Treatment of Pediatric IgA Vasculitis-Associated Nephritis: A Multicenter Clinical Study","Inclusion Criteria:\n\n1. Age 3-17 years;\n2. Patients diagnosed with IgA vasculitis nephritis (IgAVN) based on clinical manifestations and renal pathological diagnosis;\n3. Urinary protein quantification requirements: urinary protein\u002Fcreatinine ratio (UPCR) of ≥1 mg\u002Fmg (100 mg\u002Fmmol);\n4. Estimated glomerular filtration rate (eGFR) calculated using the modified Schwartz formula of ≥60 mL\u002Fmin\u002F1.73 m².\n5. Renal biopsy is optional (if a renal biopsy is performed, cases classified as International Society of Nephropathology (ISKDC) grade ≥IV must be excluded).\n\nExclusion Criteria:\n\n1. Patients with congenital or acquired immunodeficiency, or those with concurrent tuberculosis, active cytomegalovirus (CMV), Epstein-Barr virus(EBV), hepatitis B, hepatitis C, Human Immunodeficiency Virus(HIV) infection, deep fungal infections, or other active infections;\n2. Patients exhibiting the following abnormal laboratory indicators at the time of initial diagnosis: moderate to severe neutropenia (≤1000\u002FμL); moderate to severe anemia (hemoglobin \\\u003C9.0 g\u002FdL); thrombocytopenia (platelet count \\\u003C100×10\\^12\u002FL); or abnormal liver function (Alanine Aminotransferase(ALT), Aspartate Aminotransferase(AST), or bilirubin exceeding 2.5 times the upper limit of normal and persistently elevated for 2 weeks);\n3. Patients with a history of tumors or severe cardiovascular, digestive system, hematological, endocrine, or other systemic diseases;\n4. Patients with concurrent other urinary system diseases (such as hereditary kidney diseases, etc.);\n5. Subjects with severe osteoporosis requiring treatment;\n6. Subjects diagnosed with uncontrolled mental illness or intellectual disabilities;\n7. Subjects who have received B-cell targeted therapy within the last 6 months;\n8. History of major organ transplant or hematopoietic stem cell\u002Fcell\u002Fbone marrow or kidney transplant;\n9. Vaccination with live attenuated vaccines within 1 month prior to treatment;\n10. Use of various traditional Chinese medicines for treating kidney diseases during the treatment period (patients who have previously used traditional Chinese medicine can be included, but are strictly prohibited from using it after receiving treatment according to the protocol);\n11. Incomplete clinical data.","3 Years","17 Years",{"count":61,"type":21},300,"48 Weeks","OBSERVATIONAL","To further evaluate the efficacy and safety of Telitacicept in the treatment of pediatric IgA vasculitis nephritis (IgAVN) within real-world settings, this study employs a multicenter, retrospective and prospective observational research design. It aims to compare the efficacy of Telitacicept with that of glucocorticoids, thereby providing clinicians with a reference for the rational and standardized application of Telitacicept.",[28,32],[67,68,69],"IgAV nephritis","Telitacicept","Children","NOT_YET_RECRUITING","2026-01-15",{"date":73,"type":42},"2026-01-21",{"date":75,"type":21},"2026-01-01",{"date":77,"type":21},"2028-06-30",{"name":79,"class":80},"The Children's Hospital of Zhejiang University School of Medicine","OTHER",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":16,"minAge":88,"maxAge":18,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":4},"100597015","phase-3-clinical-study-on-the-efficacy-and-safety-of-telitacicept-in-the-treatment-of-pediatric-iga-nephropathy-or-iga-vasculitis-nephritis-100597015","NCT07052981","Clinical Study on the Efficacy and Safety of Telitacicept in the Treatment of Pediatric IgA Nephropathy or IgA Vasculitis Nephritis","Inclusion Criteria:\n\n* Diagnosed with IgA nephropathy (IgAN) or IgA vasculitis nephritis (IgAVN) Aged 5 to 18 years Weight ≥25 kg Moderate or heavy proteinuria At enrollment, estimated glomerular filtration rate (eGFR) ≥30 mL\u002Fmin\u002F1.73m² calculated using the Schwartz formula (36.5 × height \\[cm\\] \u002F serum creatinine \\[μmol\u002FL\\]).\n\nWilling to sign the informed consent form\n\nExclusion Criteria:\n\n* There is an ongoing infection that requires antiviral drugs or antibiotics for treatment.\n\nThe patient has received other B cell-targeting biologics within the three months prior to enrollment.\n\nPatients with uncontrolled severe hypertension or diabetes. Individuals with other autoimmune diseases, primary immunodeficiencies, or tumors.\n\nA history of organ transplantation. Patients with chronic active infections, such as Epstein-Barr virus, cytomegalovirus, or Mycobacterium tuberculosis, whose disease state may be exacerbated by the use of steroids and immunosuppressive agents.\n\nPatients with severe liver failure, heart failure, or end-stage renal disease (ESRD).\n\nAny other medical conditions that may place the patient at increased risk by participating in this study.\n\nIndividuals deemed by the investigator as unsuitable for participation in this study.",true,"5 Years",{"count":90,"type":21},124,[24],"This clinical trial is a prospective, multicenter, non-randomized controlled study designed to evaluate the efficacy and safety of Telitacicept, a novel biologic agent, in treating pediatric IgA Nephropathy (IgAN) and IgA Vasculitis Nephritis (IgAVN). The study plans to enroll 124 children aged 5-18, divided into a test group (standard therapy + Telitacicept) and a control group (standard therapy alone), with a 24-week treatment period. The primary endpoint is the change in 24-hour urine protein levels at week 24, while secondary outcomes include UPCR (urine protein-to-creatinine ratio), eGFR, and drug safety.",[94,28],"IgA Nephropathy (IgAN)","2025-07-07",{"date":97,"type":42},"2025-07-10",{"date":99,"type":21},"2025-08-01",{"date":101,"type":21},"2027-06-30",{"name":103,"class":80},"Guixia Ding"]