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Enrolling by Invitation

NCT Number: NCT07750249

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.

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).

Enrolling by Invitation

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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,

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Change in eGFR

    Time frame: Change from baseline assessed at Week 24

    Change in eGFR (CKD-EPI equation) from baseline to week 24

  2. Change in cytokine level

    Time frame: Change from baseline assessed at Week 24

    Change in cytokine levels: IL-1, IL-6, IL-10, TNF-α

  3. Change in gut microbiota composition

    Time frame: Change from baseline assessed at Week 24

    Change in gut microbiota composition (diversity indices; phylum/genus level)

  4. Change in systolic blood pressure

    Time frame: Change from baseline assessed at Week 24

    Change in systolic blood pressure

  5. Change in serum lipid profile

    Time frame: Change from baseline assessed at Week 24

    Change in serum lipid profile (cholesterol, triglycerides, etc.)

  6. Change in quality of life

    Time frame: Change from baseline assessed at Week 24

    Change in quality of life using KDQOL™-36 questionnaire

Sponsors and collaborators

Lead sponsor

University Hospital, Martin

Other

Registry information

Official study title

Modification of Intestinal Microbiome in Patients With Primary IgA Nephropathy

Acronym: MIMIGA

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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