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NCT06528015 · ClinicalTrials.gov record · last posted 2024-07-30

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

StatusNot Yet Recruiting
PhasePhase 4
SponsorGang Xu
Started2024-07
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from the ClinicalTrials.gov record
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
Trial Details
NCT Number NCT06528015
Lead Sponsor Gang Xu
Collaborators: China Primary Health Care Foundation
Conditions Glomerulonephritis, IGA, Probiotics, Budesonide
Enrollment 206 participants
Start Date 2024-07
Primary Completion 2026-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-07-30