By InvitationEarly Phase 1

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.

Slovakia120 participantsStarted 2025-03-01

Plain-language 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 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * \- 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. Inclusion Criteria for SGLT2i stable subjects * Receiving a stable dose of an SGLT2i for at least eight weeks prior to screening * Must have the spot morning urine protein-creatinine ratio \> 500 mg/g * Inclusion Criteria for Run-In Subjects * 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. Exclusion Criteria: * current diagnosis with anothe…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reduction of proteinuria

Timeframe: Change from baseline assessed at Week 12 (primary endpoint), with follow-up assessment at Week 24

Trial details

NCT IDNCT07750249

SponsorUniversity Hospital, Martin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

View on ClinicalTrials.gov More Primary IgA Nephropathy trials