[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hong Zhang\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100656203","to-assess-the-efficacy-and-safety-of-utilizing-galactose-deficient-iga1-biomarker-changes-to-guide-pathogenic-iga-targeted-therapeutic-strategies-100656203",false,"NCT07822100","To Assess the Efficacy and Safety of Utilizing Galactose-deficient IgA1 Biomarker Changes to Guide Pathogenic IgA-targeted Therapeutic Strategies","Development and Validation of a Gd-IgA1 Guided Precision Therapy System for Targeted Therapeutic Strategies of IgA Nephropathy： An Open-label, Random Controlled Trial","Inclusion Criteria:\n\n* Male or female, between 18 and 75 years age;\n* Biopsy confirmed diagnosis of primary IgA nephropathy or IgA Vasculitis-Associated Nephritis;\n* Persistent proteinuria, defined as: two separate measurements (with an interval of ≥ 4 weeks) of 24-hour urinary protein excretion (24hUTP) ≥ 0.5 g\u002Fday, or urine protein-to-creatinine ratio (UPCR) ≥ 0.44 g\u002Fg;\n* Estimated glomerular filtration rate (eGFR) (CKD-EPI) ≥ 30 ml\u002Fmin per 1.73m\\^2;\n* Have received the angiotensin converting enzyme Inhibitors(ACEI) \u002F angiotensin receptor blocker(ARB) standard treatment for 4 weeks prior to randomization;\n* Intending to receive or having received Nefecon or telitacicept treatment for ≤ 2 weeks at the time of screening.\n\nExclusion Criteria:\n\n* Secondary IgA nephropathy (excluding IgA vasculitis) caused by ankylosing spondylitis, systemic lupus erythematosus, viral hepatitis, liver cirrhosis, etc.;\n* With a known history or clinical evidence of concurrent renal diseases other than IgA nephropathy;\n* Treating with systemic corticosteroids or immunosuppressants including cyclophosphamide, azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine, rituximab, etc. within 3 months prior to randomizing;\n* Have initiated or had a dose adjustment of leflunomide, tripterygium wilfordii or hydroxychloroquine within 3 months prior to randomizing;\n* Active tuberculosis or latent carrier without treatment;\n* Herpes zoster infected patients or patients with positive HIV antibody, positive HCV antibody or HBV infection (According to the HBV screening test, a) the HBsAg-positive; b) HBsAg-negative and HBcAb-positive, the HBV-DNA should be tested to determine the situation: the HBV-DNA positive subjects should be excluded, while the HBV-DNA negative subjects can participated in.)\n* Suffering from following gastrointestinal diseases: gastric ulcer bleeding within the past 6 months, active inflammatory bowel disease, a history of major gastrointestinal surgery (e.g., gastrectomy, gastroenterostomy, or bowel resection), or pancreatic injury\u002Fpancreatitis within the past 6 months;\n* A confirmed history of osteoporosis or osteonecrosis of the femoral head;\n* Type 1 or type 2 diabetes with poor glycemic control (HbA1c \\> 8%);\n* Body mass index (BMI) \\\u003C 18.5 kg\u002Fm².;\n* Systolic blood pressure (SBP) \\> 180 mmHg or diastolic blood pressure (DBP) \\> 110 mmHg;\n* Decreased lymphocyte count (absolute value \\\u003C 1.1 × 10⁹\u002FL) or decreased immunoglobulin G (IgG \\\u003C 6 g\u002FL).\n* Hepatic dysfunction, meeting any of the following: a) Child-Pugh Class C liver dysfunction; b) ALT or AST \\> 2 × upper limit of normal (ULN), or total bilirubin \\> 2 × ULN at screening; c) history of hepatic encephalopathy, esophageal varices, or portosystemic shunt surgery;\n* Evidence of urinary tract obstruction or dysuria.\n* A history of solid organ transplantation, hematopoietic stem cell\u002Fcell\u002Fbone marrow transplantation, or kidney transplantation.\n* Pregnancy, lactation, female participants with childbearing plans during the trial or within 6 months of its completion, and male participants planning to conceive or donate sperm during the trial or within 3 months of its completion;\n* With a history of malignant tumors within the past 5 years (excluding cutaneous squamous cell carcinoma or basal cell carcinoma);\n* Allergy to human-derived biologics;\n* Nephrotoxic drugs is unavoidable during the study period;\n* Not suitable for the study judged by investigator.","ALL","18 Years","75 Years",{"count":20,"type":21},374,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this open-label, randomized study is to evaluate the efficacy and safety of the personalized treatment model in which Gd-IgA1 is dynamically monitored to guide medication adjustment in progressive IgAN patients treated with Nefecon or telitacicept.\n\nResearchers will compare two groups of participants: those who have Gd-IgA1 checked regularly during treatment, and those who do not. This is to find out if regular Gd-IgA1 checks can help doctors adjust medication better and get better treatment results.",[27,28],"IgA Nephropathy (IgAN)","Henoch Schönlein Purpura Nephritis",[30,31,32],"IgA Nephropathy","IgA Vasculitis Nephritis","Gd-IgA1","RECRUITING","2026-09-10",{"date":36,"type":37},"2026-09-16","ACTUAL",{"date":39,"type":37},"2026-08-24",{"date":41,"type":21},"2028-02",{"name":43,"class":44},"Hong Zhang","OTHER",""]