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NCT06528015

PHASE4

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

Sponsor: Gang Xu

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

206

Start Date

2024-07

Completion Date

2028-12-31

Last Updated

2024-07-30

Healthy Volunteers

Conditions

Glomerulonephritis, IGA Probiotics Budesonide

Interventions

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/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.

DRUG

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.

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.

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

Wuhan, Hubei, China