[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656203":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":38,"studyPopulation":11,"armGroups":39,"interventions":50,"overallOfficials":11,"centralContacts":56,"locations":62,"responsibleParty":78,"collaborators":11,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":11,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":11,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":64,"whyStopped":11,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"Mean change in 24-hour proteinuria from baseline at the end of follow-up",null,"From enrollment to the end of follow-up at 12 months",[14,17,20,24],{"measure":15,"description":11,"timeFrame":16},"Mean change in 24-hour proteinuria from baseline at the midpoint of follow-up","From enrollment to the middle of follow-up period at 6 months",{"measure":18,"description":19,"timeFrame":12},"Change in estimated glomerular filtration rate (eGFR)","eGFR is calculated using the CKD-EPI method.",{"measure":21,"description":22,"timeFrame":23},"Complete remission of proteinuria","24-hour urine total protein ≤ 0.3 g with a concurrent eGFR decline ≤ 30%","From enrollment to the midpoint of follow-up (6 months) and over the entire 12-month follow-up period",{"measure":25,"description":26,"timeFrame":12},"Immunosuppressant exposure measures","Cumulative dosage of non-corticosteroid immunosuppressants, cumulative dosage of systemic corticosteroids converted to prednisone-equivalent dosage, and number of corticosteroid bolus therapy courses during follow-up. Consecutive daily bolus doses count as one course; topical corticosteroids are excluded.",[28],{"measure":29,"description":30,"timeFrame":31},"The incidence rate and severity of adverse events","An adverse event is any undesirable experience associated with the study intervention in a patient.","From enrollment to the end of follow-up (12 months)",{"allocation":33,"interventionModel":34,"interventionModelDescription":11,"primaryPurpose":35,"observationalModel":11,"timePerspective":11,"maskingInfo":36},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":37,"maskingDescription":11,"whoMasked":11},"NONE","IgA nephropathy (IgAN) is the most common primary glomerulonephritis worldwide and a leading cause of end-stage renal disease (ESRD) in young adults. Even with standard supportive care, many patients still experience worsening renal function and eventually develop ESRD.\n\nThe widely accepted multi-hit pathogenesis of IgAN recognizes the production of galactose-deficient IgA1 (Gd-IgA1) as the key step. Pathogenic Gd-IgA1 forms immune complexes that deposit in the kidney, triggering inflammation and renal damage, which serves as a target for new regimens.\n\nTwo novel targeted therapies have shown positive clinical effects for IgAN:\n\n1. Budesonide Enteric Capsules (Nefecon): A gut-targeted oral preparation that releases drugs in the ileocecal region, reducing Gd-IgA1 production and renal immune deposition to protect renal function.\n2. Telitacicept: A dual Blys\u002FAPRIL inhibitor that blocks the proliferation of B cells to reduce pathogenic Gd-IgA1 production.\n\nHowever, the clinical effects of these novel therapies usually take time to appear (e.g., a significant drop in urinary protein with Nefecon is often seen 3 to 6 months after treatment). Early, sensitive indicators reflecting therapeutic effects are needed to enable timely adjustment of treatment plans.\n\nBiomarkers (e.g., Gd-IgA1) decline earlier than urinary protein, which is highly significant for monitoring early treatment efficacy and optimizing personalized treatment decisions.",[40,46],{"label":41,"type":42,"description":43,"interventionNames":44},"Participants who have Gd-IgA1 checked regularly during treatment","EXPERIMENTAL","Based on the combined results of reductions in urinary protein, Gd-IgA1 levels and other parameters, clinicians can thus evaluate early treatment efficacy and make timely medication adjustments - either continuing the original treatment, increasing the dose, or switching to another medication.",[45],"Diagnostic Test: Gd-IgA1 monitoring",{"label":47,"type":48,"description":49,"interventionNames":11},"Participants who do not have Gd-IgA1 checked during treatment","NO_INTERVENTION","Clinicians will make medication adjustment base on urinary protein and other laboratory test parameters if necessary.",[51],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":11},"DIAGNOSTIC_TEST","Gd-IgA1 monitoring","Participants in the experimental group will undergo a total of five Gd-IgA1 tests at baseline and during the follow-up period, and their clinicians will use these results to guide medication adjustment.",[41],[57],{"name":58,"role":59,"phone":60,"phoneExt":11,"email":61},"Yunfei Bao","CONTACT","086-18500228190","baoy_fei@163.com",[63],{"facility":5,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"RECRUITING","Beijing","Beijing Municipality","100010","China","CN",{"type":71,"coordinates":72},"Point",[73,74],116.39723,39.9075,{"lat":74,"lon":73},[77],{"name":58,"role":59,"phone":60,"phoneExt":11,"email":61},{"type":79,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Hong Zhang","Chief physician and Professor","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":93,"type":94},374,"ESTIMATED","INTERVENTIONAL",[97],"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.",[100,101],"IgA Nephropathy (IgAN)","Henoch Schönlein Purpura Nephritis",[103,104,105],"IgA Nephropathy","IgA Vasculitis Nephritis","Gd-IgA1","2026-09-10",{"date":108,"type":109},"2026-09-16","ACTUAL",{"date":111,"type":109},"2026-08-24",{"date":113,"type":94},"2028-02",{"name":80,"class":6},1]