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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.

NCT07750249 · Status: ENROLLING_BY_INVITATION · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-08-06

No results posted yet for this study

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).

Conditions

Interventions

DRUG

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.

Sponsors & Collaborators

  • University Hospital, Martin

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Slovakia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07750249 on ClinicalTrials.gov