[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556662":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":57,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":26,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":90,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental","EXPERIMENTAL","Experimental participants will receive probiotics combined with enteric-coated budesonide capsules",[13],"Drug: probiotics combined with enteric-coated budesonide capsule",{"label":15,"type":16,"description":17,"interventionNames":18},"Comparator","PLACEBO_COMPARATOR","Comparator participants will receive probiotics placebo combined with enteric-coated budesonide capsules",[19],"Drug: probiotics placebo combined with enteric-coated budesonide capsules",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","probiotics combined with enteric-coated budesonide capsule","In the 9-month treatment period, the following treatments will be received: probiotics combined with enteric-coated budesonide capsules group: 1 bag\u002Fday of probiotics (each bag added active probiotic Lactobacillus casei Zhang ≥100 billion CFU) +16 mg\u002Fday oral enteric-coated budesonide capsules.\n\nAfter completing the treatment period, participants will enter a 2-week reduction period to reduce the risk of adrenal insufficiency. ① enteric-coated budesonide capsules reduction: 8 mg\u002Fday oral enteric-coated budesonide capsules.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"probiotics placebo combined with enteric-coated budesonide capsules","In the 9-month treatment period, the following treatments will be received: probiotics placebo combined with enteric-coated budesonide capsules group: 1 bag\u002Fday of probiotics placebo +16 mg\u002Fday oral enteric-coated budesonide capsules.\n\nAfter completing the treatment period, participants will enter a 2-week reduction period to reduce the risk of adrenal insufficiency. ① enteric-coated budesonide capsules reduction: 8 mg\u002Fday oral enteric-coated budesonide capsules.",[15],[32],{"name":33,"affiliation":5,"role":34},"GANG XU","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"RUI ZENG","CONTACT","+86 15002726366","zengrui@tjh.tjmu.edu.cn",{"name":33,"role":38,"phone":42,"phoneExt":26,"email":43},"+86 13507181312","xugang@tjh.tjmu.edu.cn",[45],{"facility":46,"status":26,"city":47,"state":48,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":26},"Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology","Wuhan","Hubei","China","CN",{"type":52,"coordinates":53},"Point",[54,55],114.26667,30.58333,{"lat":55,"lon":54},{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Gang Xu","Professor",[62],{"name":63,"class":64},"China Primary Health Care Foundation","UNKNOWN","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":76,"type":77},206,"ESTIMATED","INTERVENTIONAL",[80],"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",[83,84,85],"Glomerulonephritis, IGA","Probiotics","Budesonide",[87,88,89],"enteric-coated budesonide capsules","probiotic","primary IgA nephropathy","NOT_YET_RECRUITING","2024-07-29",{"date":93,"type":94},"2024-07-30","ACTUAL",{"date":96,"type":77},"2024-07",{"date":98,"type":77},"2028-12-31",{"name":59,"class":6},1]