Efficacy and Safety of Probiotics Combined With Enteric-coated Budesonide Capsules in Patients With Primary IgA Nephropathy
NCT Number: NCT06528015
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Glomerulonephritis, IGA|Probiotics|Budesonide
Interventions: DRUG: probiotics combined with enteric-coated budesonide capsule|DRUG: probiotics placebo combined with enteric-coated budesonide capsules
Sponsor: Gang Xu
Collaborators: China Primary Health Care Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 206
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2028-12-31
Locations: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, Hubei, China

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

Primary Outcome Measures: UPCR, Mean change from baseline in UPCR over the 9-month treatment phase, over the 9-month treatment phase
Secondary Outcome Measures: UPCR, Mean change from baseline in UPCR at 12 months, at 12 months|24-h urine protein excretion, Mean changes from baseline in 24-h urine protein excretion at 9 and 12 months, at 9 and 12 months|UACR, Mean changes from baseline in UACR at 9 and 12 months, at 9 and 12 months|serum Gd-IgA1, Mean changes from baseline in serum Gd-IgA1 at 3, 6, 9 and 12 months, at 3, 6, 9 and 12 months|serum BAFF and APRIL, Mean changes from baseline in serum BAFF and APRIL at 12 months, at 12 months|eGFR, Mean changes from baseline in eGFR at 9 and 12 months, at 9 and 12 months|eGFR, Changes from baseline in eGFR at each visit during long-term follow-up, 12months，24months，36months after the end of treatment|UACR, Changes from baseline in UACR at each visit during long-term follow-up, 12months，24months，36months after the end of treatment|24-h urine protein excretion, Changes from baseline in 24-h urine protein excretion at each visit during long-term follow-up, 12months，24months，36months after the end of treatment|renal function (including creatinine, urea, and uric acid), Changes from baseline in renal function (including creatinine, urea, and uric acid) at each visit during long-term follow-up, 12months，24months，36months after the end of treatment