Efficacy and Safety of Probiotics Combined With Enteric-coated Budesonide Capsules in Patients With Primary IgA Nephropathy

Prior treatment

• Received organ transplants;
• Currently using a potent inhibitor of cytochrome P4503A4 (CYP3A4) and cannot be discontinued during the study;
• Known allergy or intolerance to ACEI, ARB, budesonide or any component of the investigational drug formulation;

Other illness

• 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.);
• 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;
• Complicated with malignant tumors (diagnosed within the past 5 years), cerebral infarction, cerebral hemorrhage, myocardial infarction, arrhythmia, heart failure and other serious primary diseases;
• The presence of severe chronic or active infections (including but not limited to tuberculosis) that require systemic antimicrobial, antifungal, antiviral, or antiparasitic treatment;
• A history of cirrhosis;
• Diagnosed with uncontrolled mental illness;
• Human immunodeficiency virus antibody positive, treponema pallidum antibody positive, hepatitis B surface antigen positive, hepatitis C antibody positive;

Lab values

• Participants with poorly controlled type 1 or type 2 diabetes (glycated haemoglobin \[HbA1c\] \>8%;
• Laboratory tests for abnormal liver function (ALT and/or AST\> 2 times the upper normal limit, ALP\> 2.5 times the upper normal limit);

Other

• Secondary form of IgA nephropathy or any non-IgA nephropathy Glomerulonephritis;
• 24-h urine protein excretion \>5g;
• Renal biopsy showed crescent ≥25%;
• Severe osteoporosis requiring treatment;
• Glaucoma or cataracts who currently require clinical treatment;
• The blood total cholesterol was seriously abnormal (\>12.92mmol/L);
• Use of antibiotics, glucocorticoids or other immunosuppressants, foods and medicines containing probiotics/prebiotics within the past 3 months;
• Pregnant or lactating participants;
• Also accepting participants from other clinical trials;
• Participants who have been determined by the researchers to be unable to complete on time.

• Adult age: 18\~70 years old;
• Renal biopsy-confirmed primary IgA nephropathy;
• 24-h urine protein excretion ≥ 0.75g, or urinary protein creatinine ratio (UPCR) ≥ 0.5g/g;
• eGFR ≥ 30mL/min/1.73m\^2 estimated with the Chronic Kidney Disease Epidemiology Collaboration 2009 formula (CKD-EPI2009);
• 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;
• Sign the informed consent, understand and agree to comply with the requirements of the study and the trial procedures.