Tests probiotics with budesonide capsules for a kidney disease called IgA nephropathy
Tests probiotics plus budesonide capsules in adults with IgA nephropathy, a kidney disease.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Probiotics Combined With Enteric-coated Budesonide Capsules in Patients With Primary IgA Nephropathy
Key facts
- Where
- Wuhan, ChinaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06528015, who can take part
Where in China
- Tongji Hospital, Tongji Medical College, Huazhong University of Science & TechnologyWuhan, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gang Xu
- Trial code
- NCT06528015
- Record updated
- 30 July 2024
- Original description
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.Read full original descriptionShow less
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
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
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: 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; 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; 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); 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.