Efficacy and Safety of Probiotics Combined With Enteric-coated Budesonide Capsules in Patients With Primary IgA Nephropathy
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGang Xu
About this 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
Eligibility criteria
Qualifiers
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/1.73m² estimated with the Chronic Kidney Disease Epidemiology Collaboration 2009 formula (CKD-EPI2009);
Disqualifiers
Secondary form of IgA nephropathy or any non-IgA nephropathy Glomerulonephritis;
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.);
24-h urine protein excretion >5g;
Renal biopsy showed crescent ≥25%;
Trial design
Treatments tested in this trial
- probiotics combined with enteric-coated budesonide capsule
- probiotics placebo combined with enteric-coated budesonide capsules
Treatment groups
206 Participants
are divided into 2 treatment groupsSponsors and collaborators
Gang Xu
Lead sponsor
Tongji Hospital
Sponsor institution
China Primary Health Care Foundation
Collaborator
Source ClinicalTrials.gov