Glomerulonephritis, IGAPhase 4NCT06528015
Efficacy and Safety of Probiotics Combined With Enteric-coated Budesonide Capsules in Patients With Primary IgA Nephropathy
A Phase 4 study testing probiotics combined with enteric-coated budesonide capsule in people with Glomerulonephritis, IGA and Probiotics, run by Gang Xu at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glomerulonephritis, IGA, Probiotics, Budesonide
- What is being tested?
- probiotics combined with enteric-coated budesonide capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 1 siteChina
- Study dates
- Jul 2024to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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/1.73m^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.
Who cannot join
- 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%;
- 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;
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- 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);
- Human immunodeficiency virus antibody positive, treponema pallidum antibody positive, hepatitis B surface antigen positive, hepatitis C antibody positive;
- Currently using a potent inhibitor of cytochrome P4503A4 (CYP3A4) and cannot be discontinued during the study;
- Known allergy or intolerance to ACEI, ARB, budesonide or any component of the investigational drug formulation;
- Use of antibiotics, glucocorticoids or other immunosuppressants, foods and medicines containing probiotics/prebiotics within the past 3 months;
- Pregnant or lactating participants;
- Also accepting participants from other clinical trials;
- Participants who have been determined by the researchers to be unable to complete on time.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei
About this study
Official title: Efficacy and Safety of Probiotics Combined With Enteric-coated Budesonide Capsules in Patients With Primary IgA Nephropathy: a Prospective, Multicenter, Randomized, Single-blind, Placebo-controlled Clinical 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:
Read more
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
Read the detailed description
This is a prospective, multicenter, randomized, single-blind, placebo-controlled clinical trial. The study included a screening period (7-15 days), an induction period (at least 3 months), randomization, a treatment period (9 months), a reduction period (2 weeks), a safety follow-up period (2.5 months), and a long-term follow-up period (36 months). Participants who meet the randomization criteria will be randomly assigned (1:1) to receive probiotics combined with enteric-coated budesonide capsules or probiotics placebo combined with enteric-coated budesonide capsules.
Screening period (7-15 days): Participants who sign the informed consent for this study and undergo relevant examinations can enter the induction period if they meet the screening criteria.
Induction period (at least 3 months): Optimized treatment with RAS blockers is performed immediately upon entry the induction period.
Randomization: RAS blockers were used for at least 3 months during the induction period. All inclusion conditions had to be met to qualify for randomization.
Treatment period (9 months): Participants who meet the randomization criteria will be randomly assigned (1:1) to receive probiotics combined with enteric-coated budesonide capsules group or probiotics placebo combined with enteric-coated budesonide capsules. In the 9-month treatment period, the following treatments will be received: ① 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. ② probiotics placebo combined with enteric-coated budesonide capsules group: 1 bag/day of probiotics placebo +16 mg/day oral enteric-coated budesonide capsules.
The RAS blocker (ACEI or ARB) dosing regimen needs to be stable during treatment period.
Reduction period (2 weeks): 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.
The RAS blocker (ACEI or ARB) dosing regimen needs to be stable during reduction period.
Safety follow-up period (2.5 months): After completion of the reduction period, all participants stopped taking the investigational drug, completed the remainder of the safety follow-up period. During this time, the RAS blocker (ACEI or ARB) dosing regimen needs to be stable.
Long-term follow-up period (36 months): Participants who have completed the treatment period, reduction period, and safety follow-up period, as well as those who terminated the study treatment early but did not withdraw from the study, will enter long-term follow-up.
- Conditions
- Glomerulonephritis, IGA, Probiotics, Budesonide
- Being tested
- probiotics combined with enteric-coated budesonide capsule, probiotics placebo combined with enteric-coated budesonide capsules
- Keywords
- enteric-coated budesonide capsules, probiotic, primary IgA nephropathy
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotics combined with enteric-coated budesonide capsuleDrug
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 capsulesDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Experimental participants will receive probiotics combined with enteric-coated budesonide capsules Receives: Drug: probiotics combined with enteric-coated budesonide capsule |
| Comparator | Placebo comparator | Comparator participants will receive probiotics placebo combined with enteric-coated budesonide capsules Receives: Drug: probiotics placebo combined with enteric-coated budesonide capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
UPCR
Mean change from baseline in UPCR over the 9-month treatment phase
Measured: over the 9-month treatment phase
Secondary outcomes (10)
UPCR
Mean change from baseline in UPCR at 12 months
Measured: at 12 months
24-h urine protein excretion
Mean changes from baseline in 24-h urine protein excretion at 9 and 12 months
Measured: at 9 and 12 months
UACR
Mean changes from baseline in UACR at 9 and 12 months
Measured: at 9 and 12 months
serum Gd-IgA1
Mean changes from baseline in serum Gd-IgA1 at 3, 6, 9 and 12 months
Measured: at 3, 6, 9 and 12 months
serum BAFF and APRIL
Mean changes from baseline in serum BAFF and APRIL at 12 months
Measured: at 12 months
eGFR
Mean changes from baseline in eGFR at 9 and 12 months
Measured: at 9 and 12 months
eGFR
Changes from baseline in eGFR at each visit during long-term follow-up
Measured: 12months，24months，36months after the end of treatment
UACR
Changes from baseline in UACR at each visit during long-term follow-up
Measured: 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
Measured: 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
Measured: 12months，24months，36months after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study startJul 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glomerulonephritis, IGAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gang Xu
- Sponsor type
- University, hospital or other
- Collaborators
- China Primary Health Care Foundation
- Responsible party
- Sponsor-investigator, Gang Xu, Tongji Hospital
- Investigators
- GANG XU, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528015
- Sponsor's protocol ID
- TongjiHospitalxugangtjh123
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Probiotics Combined With Enteric-coated Budesonide Capsules in Patients With Primary IgA Nephropathy: a Prospective, Multicenter, Randomized, Single-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06528015
- Acronym / sponsor ID
- TongjiHospitalxugangtjh123
- Conditions
- Glomerulonephritis, IGA, Probiotics, Budesonide
- Keywords
- enteric-coated budesonide capsules, probiotic, primary IgA nephropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Gang XuUniversity, hospital or other
- Collaborators
- China Primary Health Care Foundation
- Study start
- Jul 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a prospective, multicenter, randomized, single-blind, placebo-controlled clinical trial. The study included a screening period (7-15 days), an induction period (at least 3 months), randomization, a treatment period (9 months), a reduction period (2 weeks), a safety follow-up period (2.5 months), and a long-term follow-up period (36 months). Participants who meet the randomization criteria will be randomly assigned (1:1) to receive probiotics combined with enteric-coated budesonide capsules or probiotics placebo combined with enteric-coated budesonide capsules.
Screening period (7-15 days): Participants who sign the informed consent for this study and undergo relevant examinations can enter the induction period if they meet the screening criteria.
Induction period (at least 3 months): Optimized treatment with RAS blockers is performed immediately upon entry the induction period.
Randomization: RAS blockers were used for at least 3 months during the induction period. All inclusion conditions had to be met to qualify for randomization.
Treatment period (9 months): Participants who meet the randomization criteria will be randomly assigned (1:1) to receive probiotics combined with enteric-coated budesonide capsules group or probiotics placebo combined with enteric-coated budesonide capsules. In the 9-month treatment period, the following treatments will be received: ① 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. ② probiotics placebo combined with enteric-coated budesonide capsules group: 1 bag/day of probiotics placebo +16 mg/day oral enteric-coated budesonide capsules.
The RAS blocker (ACEI or ARB) dosing regimen needs to be stable during treatment period.
Reduction period (2 weeks): 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.
The RAS blocker (ACEI or ARB) dosing regimen needs to be stable during reduction period.
Safety follow-up period (2.5 months): After completion of the reduction period, all participants stopped taking the investigational drug, completed the remainder of the safety follow-up period. During this time, the RAS blocker (ACEI or ARB) dosing regimen needs to be stable.
Long-term follow-up period (36 months): Participants who have completed the treatment period, reduction period, and safety follow-up period, as well as those who terminated the study treatment early but did not withdraw from the study, will enter long-term follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: probiotics combined with enteric-coated budesonide capsuleExperimental participants will receive probiotics combined with enteric-coated budesonide capsules |
| Comparator | Placebo comparator | Drug: probiotics placebo combined with enteric-coated budesonide capsulesComparator participants will receive probiotics placebo combined with enteric-coated budesonide capsules |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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/1.73m^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;
Key exclusion criteria (22 listed)
- 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%;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probiotics combined with enteric-coated budesonide capsuleIn 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. | Drug | Experimental |
| probiotics placebo combined with enteric-coated budesonide capsulesIn 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. | Drug | Comparator |
Primary outcome
UPCR
Time frame: over the 9-month treatment phase
Mean change from baseline in UPCR over the 9-month treatment phase
10 secondary outcomes
UPCR
Time frame: at 12 months
24-h urine protein excretion
Time frame: at 9 and 12 months
UACR
Time frame: at 9 and 12 months
serum Gd-IgA1
Time frame: at 3, 6, 9 and 12 months
serum BAFF and APRIL
Time frame: at 12 months
eGFR
Time frame: at 9 and 12 months
eGFR
Time frame: 12months，24months，36months after the end of treatment
UACR
Time frame: 12months，24months，36months after the end of treatment
24-h urine protein excretion
Time frame: 12months，24months，36months after the end of treatment
renal function (including creatinine, urea, and uric acid)
Time frame: 12months，24months，36months after the end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
GANG XU principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing probiotics combined with enteric-coated budesonide capsule in people with Glomerulonephritis, IGA and Probiotics, run by Gang Xu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact RUI ZENG (+86 15002726366, zengrui@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UPCR (time frame: over the 9-month treatment phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.