Starting soon
Phase 4
Efficacy and Safety of Probiotics Combined With Enteric-coated Budesonide Capsules in Patients With Primary IgA Nephropathy
Condition(s) studied
Glomerulonephritis, IGAProbioticsBudesonide
Investigational drug(s) / intervention(s)
probiotics combined with enteric-coated budesonide capsuleprobiotics placebo combined with enteric-coated budesonide capsules
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/day of probiotics (each bag added active probiotic Lactobacillus casei Zhang ≥100 billion CFU) +16 mg/day oral enteric-coated budesonide capsules.
After 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/day oral enteric-coated budesonide capsules.
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/day of probiotics placebo +16 mg/day oral enteric-coated budesonide capsules.
After 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/day oral enteric-coated budesonide capsules.
Study 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 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.
The main questions it aims to answer are:
Dose 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?
Participants will:
Take 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
Eligibility
Inclusion Criteria:
1. Adult age: 18\~70 years old;
2. Renal biopsy-confirmed primary IgA nephropathy;
3. 24-h urine protein excretion ≥ 0.75g, or urinary protein creatinine ratio (UPCR) ≥ 0.5g/g;
4. eGFR ≥ 30mL/min/1.73m\^2 estimated with the Chronic Kidney Disease Epidemiology Collaboration 2009 formula (CKD-EPI2009);
5. 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;
6. Sign the informed consent, understand and agree to comply with the requirements of the study and the trial procedures.
Exclusion Criteria:
1. Secondary form of IgA nephropathy or any non-IgA nephropathy Glomerulonephritis;
2. 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.);
3. 24-h urine protein excretion \>5g;
4. Renal biopsy showed crescent ≥25%;
5. 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;
6. Complicated with malignant tumors (diagnosed within the past 5 years), cerebral infarction, cerebral hemorrhage, myocardial infarction, arrhythmia, heart failure and other serious primary diseases;
7. The presence of severe chronic or active infections (including but not limited to tuberculosis) that require systemic antimicrobial, antifungal, antiviral, or antiparasitic treatment;
8. A history of cirrhosis;
9. Severe osteoporosis requiring treatment;
10. Received organ transplants;
11. Glaucoma or cataracts who currently require clinical treatment;
12. Diagnosed with uncontrolled mental illness;
13. Participants with poorly controlled type 1 or type 2 diabetes (glycated haemoglobin \[HbA1c\] \>8%;
14. Laboratory tests for abnormal liver function (ALT and/or AST\> 2 times the upper normal limit, ALP\> 2.5 times the upper normal limit);
15. The blood total cholesterol was seriously abnormal (\>12.92mmol/L);
16. Human immunodeficiency virus antibody positive, treponema pallidum antibody positive, hepatitis B surface antigen positive, hepatitis C antibody positive;
17. Currently using a potent inhibitor of cytochrome P4503A4 (CYP3A4) and cannot be discontinued during the study;
18. Known allergy or intolerance to ACEI, ARB, budesonide or any component of the investigational drug formulation;
19. Use of antibiotics, glucocorticoids or other immunosuppressants, foods and medicines containing probiotics/prebiotics within the past 3 months;
20. Pregnant or lactating participants;
21. Also accepting participants from other clinical trials;
22. Participants who have been determined by the researchers to be unable to complete on time.
Primary outcome measure(s)
- UPCR — over the 9-month treatment phase
Mean change from baseline in UPCR over the 9-month treatment phase
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology |
Wuhan |
Hubei |
|
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