[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Gang Xu\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"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":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100556662","phase-4-efficacy-and-safety-of-probiotics-combined-with-enteric-coated-budesonide-capsules-in-patients-with-primary-iga-nephropathy-100556662",false,"NCT06528015","Efficacy and Safety of Probiotics Combined With Enteric-coated Budesonide Capsules in Patients With Primary IgA Nephropathy","Efficacy and Safety of Probiotics Combined With Enteric-coated Budesonide Capsules in Patients With Primary IgA Nephropathy: a Prospective, Multicenter, Randomized, Single-blind, Placebo-controlled Clinical Trial","Inclusion Criteria:\n\n1. Adult age: 18\\~70 years old;\n2. Renal biopsy-confirmed primary IgA nephropathy;\n3. 24-h urine protein excretion ≥ 0.75g, or urinary protein creatinine ratio (UPCR) ≥ 0.5g\u002Fg;\n4. eGFR ≥ 30mL\u002Fmin\u002F1.73m\\^2 estimated with the Chronic Kidney Disease Epidemiology Collaboration 2009 formula (CKD-EPI2009);\n5. Fertile men and female of childbearing age need to use highly effective contraceptive measures from the time they sign informed consent to the end of the safety follow-up period;\n6. Sign the informed consent, understand and agree to comply with the requirements of the study and the trial procedures.\n\nExclusion Criteria:\n\n1. Secondary form of IgA nephropathy or any non-IgA nephropathy Glomerulonephritis;\n2. Specific types of IgA nephropathy (including minor lesions with mesangial IgA deposition, rapidly progressive and crescentic IgA nephropathy, etc.) and other glomerular diseases (such as diabetic nephropathy, etc.);\n3. 24-h urine protein excretion \\>5g;\n4. Renal biopsy showed crescent ≥25%;\n5. A history of severe gastrointestinal disease (such as active peptic ulcer disease, active gastrointestinal bleeding, gastrointestinal perforation, inflammatory bowel disease, and chronic diarrhea) or a history of gastrointestinal surgery;\n6. Complicated with malignant tumors (diagnosed within the past 5 years), cerebral infarction, cerebral hemorrhage, myocardial infarction, arrhythmia, heart failure and other serious primary diseases;\n7. The presence of severe chronic or active infections (including but not limited to tuberculosis) that require systemic antimicrobial, antifungal, antiviral, or antiparasitic treatment;\n8. A history of cirrhosis;\n9. Severe osteoporosis requiring treatment;\n10. Received organ transplants;\n11. Glaucoma or cataracts who currently require clinical treatment;\n12. Diagnosed with uncontrolled mental illness;\n13. Participants with poorly controlled type 1 or type 2 diabetes (glycated haemoglobin \\[HbA1c\\] \\>8%;\n14. Laboratory tests for abnormal liver function (ALT and\u002For AST\\> 2 times the upper normal limit, ALP\\> 2.5 times the upper normal limit);\n15. The blood total cholesterol was seriously abnormal (\\>12.92mmol\u002FL);\n16. Human immunodeficiency virus antibody positive, treponema pallidum antibody positive, hepatitis B surface antigen positive, hepatitis C antibody positive;\n17. Currently using a potent inhibitor of cytochrome P4503A4 (CYP3A4) and cannot be discontinued during the study;\n18. Known allergy or intolerance to ACEI, ARB, budesonide or any component of the investigational drug formulation;\n19. Use of antibiotics, glucocorticoids or other immunosuppressants, foods and medicines containing probiotics\u002Fprebiotics within the past 3 months;\n20. Pregnant or lactating participants;\n21. Also accepting participants from other clinical trials;\n22. Participants who have been determined by the researchers to be unable to complete on time.","ALL","18 Years","70 Years",{"count":20,"type":21},206,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The goal of this clinical trial is to evaluate the efficacy and safety of probiotics combined with enteric-coated budesonide capsule in patients with IgA nephropathy on the basis of optimized RAS blockade therapy, and to explore the correlation between the efficacy of probiotics combined with enteric-coated budesonide capsule in the treatment of primary IgA nephropathy and intestinal homeostasis.\n\nThe main questions it aims to answer are:\n\nDose probiotics combined with enteric-coated budesonide capsule provide a durable reduction in urine protein creatinine ratio (UPCR) in participants, compared with probiotics placebo combined with enteric-coated budesonide capsule? What medical problems do participants have when taking probiotics combined with enteric-coated budesonide capsule?\n\nParticipants will:\n\nTake probiotics combined with enteric-coated budesonide capsules or probiotics placebo combined with enteric-coated budesonide capsules every day for 9.5 month Participate in center site follow-up visits for 13 times Keep a diary of their symptoms and outcomes",[27,28,29],"Glomerulonephritis, IGA","Probiotics","Budesonide",[31,32,33],"enteric-coated budesonide capsules","probiotic","primary IgA nephropathy","NOT_YET_RECRUITING","2024-07-29",{"date":37,"type":38},"2024-07-30","ACTUAL",{"date":40,"type":21},"2024-07",{"date":42,"type":21},"2028-12-31",{"name":44,"class":45},"Gang Xu","OTHER",""]