Status:
NOT_YET_RECRUITING
Efficacy and Safety of Probiotics Combined With Enteric-coated Budesonide Capsules in Patients With Primary IgA Nephropathy
Lead Sponsor:
Gang Xu
Collaborating Sponsors:
China Primary Health Care Foundation
Conditions:
Glomerulonephritis, IGA
Probiotics
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
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 bloc...
Detailed Description
This is a prospective, multicenter, randomized, single-blind, placebo-controlled clinical trial. The study included a screening period (7-15 days), an induction period (at least 3 months), randomizati...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Secondary form of IgA nephropathy or any non-IgA nephropathy Glomerulonephritis;
- 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.);
- 24-h urine protein excretion \>5g;
- Renal biopsy showed crescent ≥25%;
- 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;
- Severe osteoporosis requiring treatment;
- Received organ transplants;
- Glaucoma or cataracts who currently require clinical treatment;
- Diagnosed with uncontrolled mental illness;
- 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);
- The blood total cholesterol was seriously abnormal (\>12.92mmol/L);
- Human immunodeficiency virus antibody positive, treponema pallidum antibody positive, hepatitis B surface antigen positive, hepatitis C antibody positive;
- 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;
- 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.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT06528015
Start Date
July 1 2024
End Date
December 31 2028
Last Update
July 30 2024
Active Locations (1)
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1
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China