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

NCT06528015 | Not Yet Recruiting Phase 4

• 1 other identifier: TongjiHospitalxugangtjh123
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Glomerulonephritis, IGA; Probiotics; Budesonide

Keywords

enteric-coated budesonide capsules; probiotic; primary IgA nephropathy

Outcome Measures

Primary Outcomes (1)

• UPCR

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

  over the 9-month treatment phase

Secondary Outcomes (10)

• UPCR

  at 12 months

• 24-h urine protein excretion

  at 9 and 12 months

• UACR

  at 9 and 12 months

• serum Gd-IgA1

  at 3, 6, 9 and 12 months

• serum BAFF and APRIL

  at 12 months

Study Arms (2)

Experimental

EXPERIMENTAL

Experimental participants will receive probiotics combined with enteric-coated budesonide capsules

Drug: probiotics combined with enteric-coated budesonide capsule

Comparator

PLACEBO COMPARATOR

Comparator participants will receive probiotics placebo combined with enteric-coated budesonide capsules

Drug: probiotics placebo combined with enteric-coated budesonide capsules

Interventions

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.

Experimental

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.

Comparator

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult age: 18\~70 years old;
• Renal biopsy-confirmed primary IgA nephropathy;
• 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.

You may not qualify if:

• 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.);
• h urine protein excretion \>5g;
• Renal biopsy showed crescent ≥25%;
• 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;
• Severe osteoporosis requiring treatment;
• Received organ transplants;
• Glaucoma or cataracts who currently require clinical treatment;
• Diagnosed with uncontrolled mental illness;
• 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);
• The blood total cholesterol was seriously abnormal (\>12.92mmol/L);

Sponsors & Collaborators

• Gang Xu: lead
• China Primary Health Care Foundation: collaborator

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

Wuhan, Hubei, China

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• GANG XU

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RUI ZENG

CONTACT

+86 15002726366; zengrui@tjh.tjmu.edu.cn

GANG XU

CONTACT

+86 13507181312; xugang@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 30, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

CN (1)