Primary IgA NephropathyEarly Phase 1MIMIGANCT07750249
The MIMIGA Study is a Randomized, Double-blind, Placebo-controlled Crossover Trial Evaluating the Safety and Efficacy of SCFA vs. Placebo. Administered Orally Once Daily With Standard Care, it Aims to Prevent CKD Progression in Biopsy-proven IgA Nephropathy by Modulating the Gut Microbiome.
A Early Phase 1 study of Primary IgA Nephropathy, run by University Hospital, Martin at 1 site in Slovakia.
Trial summary
MIMIGA Study Title: Modification of Intestinal Microbiome in Patients with Primary IgA Nephropathy (IgAN) Objective: To evaluate whether supplementation with short-chain fatty acids (SCFAs)-specifically sodium butyrate-can reduce proteinuria and slow the progression of chronic kidney disease (CKD) in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary IgA Nephropathy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Mar 2025to 31 Dec 2028
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Subjects aged 18 and older at the time of signing the informed consent form (ICF) before initiating any study specific activities/procedures.
- Biopsy-proven IgA nephropathy.
- Receiving a maximally tolerated and stable dose of RAS inhibitor therapy (ACEi or ARB) for at least 12 weeks prior to screening. Investigator discretion should be used in determining maximally tolerated and stable dose.
- eGFR of at least 30 ml/min/1.73 m2 at screening based on the CKD-EPI equation.
- Willing and able to provide informed consent and comply with all study requirements.
- Receiving a stable dose of an SGLT2i for at least eight weeks prior to screening
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- Must have the spot morning urine protein-creatinine ratio > 500 mg/g
- Must have the spot morning urine protein-creatinine ratio > 850 mg/g at screening
- Willing to participate in an 8-week run-in period with an SGLT2i Additional Inclusion Criteria for Run-in Subjects at the end of Run-In
- Must have completed the 8-week run-in period on a stable and well-tolerated dose of an SGLT2i
- Must have the spot morning urine protein-creatinine ratio > 500 mg/g confirmed at the Week -1 Visit
- Must have an eGFR of ≥ 30 ml/min/1.73 m2 based on the CKD-EPI equation at the Week -1 Visit
- Receiving treatment with SGLT2i at a stable dose for at least eight weeks prior to screening.
Who cannot join
- current diagnosis with another chronic kidney disease, including diabetic kidney disease,secondary IgAN, type 1 or 2 diabetes mellitus
- gastrointestinal diseases (such as IBD, peptic ulcers etc.),
- another immunological or autoimmune disorders
- alcohol abuse
- psychiatric disease and inability to assess follow-up
- +history of kidney transplantation or another organ transplantation,
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- use of systemic immunosuppressant medications, such as steroids, in the past 3 months, use of ATB in the past three months
- blood pressure above 150 mmHg systolic or 95 mmHg diastolic
- clinically significant history of liver disease (aspartate transaminase [AST] or alanine ttransaminase [ALT] >3x the upper limit of normal [ULN]; or total bilirubin >2x ULN at time of enrolment)
- For women - pregnancy, breastfeeding, or intent to become pregnant during the study
- For men - intent to father a child or donate sperm during the study
- If the patient has received any investigational agent or approved treatment for IgAN (other than a RAS inhibitor) within one month (or five half-lives of the agent, whichever is longer) prior to Screening, if the investigational agent is a cytotoxic or mmunosuppressive, then this washout period is six months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Modification of Intestinal Microbiome in Patients With Primary IgA Nephropathy
MIMIGA Study
Title:
Read more
Modification of Intestinal Microbiome in Patients with Primary IgA Nephropathy (IgAN)
Objective:
To evaluate whether supplementation with short-chain fatty acids (SCFAs)-specifically sodium butyrate-can reduce proteinuria and slow the progression of chronic kidney disease (CKD) in patients with IgAN by modulating the gut microbiome.
Study Design:
Type: Randomized, double-blind, placebo-controlled, crossover clinical trial.
Participants: Adults with biopsy-proven IgA nephropathy and matched healthy controls.
Phases:
Treatment Period 1: 12 weeks of SCFA or placebo.
Washout Period: 12 weeks.
Treatment Period 2: Crossover-those who received SCFA get placebo and vice versa for 24 weeks.
Follow-up: 4-8 weeks post-treatment.
Primary Endpoint:
≥25% reduction in proteinuria (urinary protein-creatinine ratio) from baseline at week 12 and 24.
Secondary and Exploratory Endpoints:
Changes in:
eGFR (kidney function)
Inflammatory cytokines (IL-1, IL-6, IL-10, TNF-α)
Gut microbiome composition (via 16S rRNA sequencing)
Progression to CKD stage 4
Systolic blood pressure
Serum lipids
Quality of life (KDQOL-36 questionnaire)
Safety Monitoring:
Adverse events, especially gastrointestinal issues.
Blood and urine biochemistry.
Clinical symptoms and patient-reported outcomes.
Eligibility Criteria:
Inclusion: Adults with IgAN, stable on RAS inhibitors, eGFR ≥ 30 ml/min/1.73 m².
Exclusion: Diabetes, other kidney or autoimmune diseases, recent use of immunosuppressants or antibiotics, uncontrolled hypertension, liver disease, pregnancy.
Microbiome Analysis:
DNA from stool samples analyzed using next-generation sequencing (NGS) targeting the V3-V4 regions of the 16S rRNA gene.
Expected Impact:
Provide first clinical evidence for SCFA as a safe, cost-effective therapy to slow CKD progression in IgAN.
Open new research directions for gut microbiome-targeted treatments in nephrology and other fields (e.g., diabetes, immunology).
- Conditions
- Primary IgA Nephropathy
- Being tested
- SCFA → Placebo (Sequence SP) and Placebo → SCFA (Sequence PS)
- Keywords
- IgA nephropathy (IgAN), Chronic kidney disease (CKD), Randomized controlled trial (RCT), Gut microbiome, Short-chain fatty acids (SCFAs)
- Medical subject headings
- Glomerulonephritis, IGA, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCFA → Placebo (Sequence SP) and Placebo → SCFA (Sequence PS)Drug
Drug: Sodium Butyrate (SCFA) Oral sodium butyrate 400 mg capsule once daily, double-blind; matching appearance to placebo. Sequence A: SCFA for 12 weeks → 12-week washout → placebo for 24 weeks.
Drug: Placebo Matching oral capsule once daily, no active SCFA, double-blind. Sequence B: Placebo for 12 weeks → 12-week washout → sodium butyrate 400 mg once daily for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SCFA → Placebo (Sequence SP) | Active comparator | Participants in this arm will:
First receive SCFA (sodium butyrate) 400 mg once daily for 12 weeks (Treatment Period 1)
Undergo a 12-week washout period
Then switch to placebo for 24 weeks (Treatment Period 2) Receives: Drug: SCFA → Placebo (Sequence SP) and Placebo → SCFA (Sequence PS) |
| Placebo → SCFA (Sequence PS) | Placebo comparator | Participants in this arm will:
First receive placebo for 12 weeks (Treatment Period 1)
Undergo a 12-week washout period
Then switch to SCFA (sodium butyrate) 400 mg once daily for 24 weeks (Treatment Period 2) Receives: Drug: SCFA → Placebo (Sequence SP) and Placebo → SCFA (Sequence PS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of proteinuria
Reduction of proteinuria by ≥25% from baseline, measured using the spot morning urine protein-creatinine ratio (UPCR)
Measured: Change from baseline assessed at Week 12 (primary endpoint), with follow-up assessment at Week 24
Secondary outcomes (6)
Change in eGFR
Change in eGFR (CKD-EPI equation) from baseline to week 24
Measured: Change from baseline assessed at Week 24
Change in cytokine level
Change in cytokine levels: IL-1, IL-6, IL-10, TNF-α
Measured: Change from baseline assessed at Week 24
Change in gut microbiota composition
Change in gut microbiota composition (diversity indices; phylum/genus level)
Measured: Change from baseline assessed at Week 24
Change in systolic blood pressure
Change in systolic blood pressure
Measured: Change from baseline assessed at Week 24
Change in serum lipid profile
Change in serum lipid profile (cholesterol, triglycerides, etc.)
Measured: Change from baseline assessed at Week 24
Change in quality of life
Change in quality of life using KDQOL™-36 questionnaire
Measured: Change from baseline assessed at Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Mar 2025
- Primary completion31 Dec 2028 (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 Primary IgA NephropathyStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Martin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matej Vnucak, University Hospital, Martin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750249
- Sponsor's protocol ID
- VV-MVP-24-0252
- Other IDs
- VV-MVP-24-0252
- Acronym
- MIMIGA
- Status last verified
- Mar 2026
- First submitted
- 19 Sep 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification of Intestinal Microbiome in Patients With Primary IgA Nephropathy
- ClinicalTrials.gov ID
- NCT07750249
- Acronym / sponsor ID
- MIMIGA / VV-MVP-24-0252
- Conditions
- Primary IgA Nephropathy
- Keywords
- IgA nephropathy (IgAN), Chronic kidney disease (CKD), Randomized controlled trial (RCT), Gut microbiome, Short-chain fatty acids (SCFAs)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, MartinUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Aug 2026 (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.
MIMIGA Study
Title:
Modification of Intestinal Microbiome in Patients with Primary IgA Nephropathy (IgAN)
Objective:
To evaluate whether supplementation with short-chain fatty acids (SCFAs)-specifically sodium butyrate-can reduce proteinuria and slow the progression of chronic kidney disease (CKD) in patients with IgAN by modulating the gut microbiome.
Study Design:
Type: Randomized, double-blind, placebo-controlled, crossover clinical trial.
Participants: Adults with biopsy-proven IgA nephropathy and matched healthy controls.
Phases:
Treatment Period 1: 12 weeks of SCFA or placebo.
Washout Period: 12 weeks.
Treatment Period 2: Crossover-those who received SCFA get placebo and vice versa for 24 weeks.
Follow-up: 4-8 weeks post-treatment.
Primary Endpoint:
≥25% reduction in proteinuria (urinary protein-creatinine ratio) from baseline at week 12 and 24.
Secondary and Exploratory Endpoints:
Changes in:
eGFR (kidney function)
Inflammatory cytokines (IL-1, IL-6, IL-10, TNF-α)
Gut microbiome composition (via 16S rRNA sequencing)
Progression to CKD stage 4
Systolic blood pressure
Serum lipids
Quality of life (KDQOL-36 questionnaire)
Safety Monitoring:
Adverse events, especially gastrointestinal issues.
Blood and urine biochemistry.
Clinical symptoms and patient-reported outcomes.
Eligibility Criteria:
Inclusion: Adults with IgAN, stable on RAS inhibitors, eGFR ≥ 30 ml/min/1.73 m².
Exclusion: Diabetes, other kidney or autoimmune diseases, recent use of immunosuppressants or antibiotics, uncontrolled hypertension, liver disease, pregnancy.
Microbiome Analysis:
DNA from stool samples analyzed using next-generation sequencing (NGS) targeting the V3-V4 regions of the 16S rRNA gene.
Expected Impact:
Provide first clinical evidence for SCFA as a safe, cost-effective therapy to slow CKD progression in IgAN.
Open new research directions for gut microbiome-targeted treatments in nephrology and other fields (e.g., diabetes, immunology).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCFA → Placebo (Sequence SP) | Active comparator | Drug: SCFA → Placebo (Sequence SP) and Placebo → SCFA (Sequence PS)Participants in this arm will: First receive SCFA (sodium butyrate) 400 mg once daily for 12 weeks (Treatment Period 1) Undergo a 12-week washout period Then switch to placebo for 24 weeks (Treatment Period 2) |
| Placebo → SCFA (Sequence PS) | Placebo comparator | Drug: SCFA → Placebo (Sequence SP) and Placebo → SCFA (Sequence PS)Participants in this arm will: First receive placebo for 12 weeks (Treatment Period 1) Undergo a 12-week washout period Then switch to SCFA (sodium butyrate) 400 mg once daily for 24 weeks (Treatment Period 2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- - Subjects aged 18 and older at the time of signing the informed consent form (ICF) before initiating any study specific activities/procedures.
- Biopsy-proven IgA nephropathy.
- Receiving a maximally tolerated and stable dose of RAS inhibitor therapy (ACEi or ARB) for at least 12 weeks prior to screening. Investigator discretion should be used in determining maximally tolerated and stable dose.
- eGFR of at least 30 ml/min/1.73 m2 at screening based on the CKD-EPI equation.
- Willing and able to provide informed consent and comply with all study requirements.
Key exclusion criteria (12 listed)
- current diagnosis with another chronic kidney disease, including diabetic kidney disease,secondary IgAN, type 1 or 2 diabetes mellitus
- gastrointestinal diseases (such as IBD, peptic ulcers etc.),
- another immunological or autoimmune disorders
- alcohol abuse
- psychiatric disease and inability to assess follow-up
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 |
|---|---|---|
| SCFA → Placebo (Sequence SP) and Placebo → SCFA (Sequence PS)Drug: Sodium Butyrate (SCFA) Oral sodium butyrate 400 mg capsule once daily, double-blind; matching appearance to placebo. Sequence A: SCFA for 12 weeks → 12-week washout → placebo for 24 weeks. Drug: Placebo Matching oral capsule once daily, no active SCFA, double-blind. Sequence B: Placebo for 12 weeks → 12-week washout → sodium butyrate 400 mg once daily for 24 weeks. | Drug | Placebo → SCFA (Sequence PS), SCFA → Placebo (Sequence SP) |
Primary outcome
Reduction of proteinuria
Time frame: Change from baseline assessed at Week 12 (primary endpoint), with follow-up assessment at Week 24
Reduction of proteinuria by ≥25% from baseline, measured using the spot morning urine protein-creatinine ratio (UPCR)
6 secondary outcomes
Change in eGFR
Time frame: Change from baseline assessed at Week 24
Change in cytokine level
Time frame: Change from baseline assessed at Week 24
Change in gut microbiota composition
Time frame: Change from baseline assessed at Week 24
Change in systolic blood pressure
Time frame: Change from baseline assessed at Week 24
Change in serum lipid profile
Time frame: Change from baseline assessed at Week 24
Change in quality of life
Time frame: Change from baseline assessed at Week 24
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 6 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study of Primary IgA Nephropathy, run by University Hospital, Martin at 1 site in Slovakia.
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 13 inclusion and 12 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: enrolling by invitation, as of the sponsor's last update on 6 Aug 2026. 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 Slovakia. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of proteinuria (time frame: Change from baseline assessed at Week 12 (primary endpoint), with follow-up assessment at Week 24). 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 6 Aug 2026.