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

ConditionsGlomerulonephritis, IGAProbioticsBudesonide
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • probiotics combined with enteric-coated budesonide capsule

    Drug

    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.

  • probiotics placebo combined with enteric-coated budesonide capsules

    Drug

    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.

Treatment groups

206 Participants
are divided into 2 treatment groups
Group A: ExperimentalExperimental treatment 1 intervention
Group B: ComparatorPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

UPCR

Mean change from baseline in UPCR over the 9-month treatment phase

Time frame
over the 9-month treatment phase

Secondary outcomes

1

UPCR

Mean change from baseline in UPCR at 12 months

Time frame
at 12 months
2

24-h urine protein excretion

Mean changes from baseline in 24-h urine protein excretion at 9 and 12 months

Time frame
at 9 and 12 months
3

UACR

Mean changes from baseline in UACR at 9 and 12 months

Time frame
at 9 and 12 months
4

serum Gd-IgA1

Mean changes from baseline in serum Gd-IgA1 at 3, 6, 9 and 12 months

Time frame
at 3, 6, 9 and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gang Xu

Lead sponsor

Tongji Hospital

Sponsor institution

China Primary Health Care Foundation

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: