University Hospital Martin
Martin, 036 01, Slovakia
NCT Number: NCT07750249
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Early Phase 1
Martin, 036 01, Slovakia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
for SGLT2i stable subjects
Exclusion criteria
+history of kidney transplantation or another organ transplantation,
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.
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)
Time frame: Change from baseline assessed at Week 24
Change in eGFR (CKD-EPI equation) from baseline to week 24
Time frame: Change from baseline assessed at Week 24
Change in cytokine levels: IL-1, IL-6, IL-10, TNF-α
Time frame: Change from baseline assessed at Week 24
Change in gut microbiota composition (diversity indices; phylum/genus level)
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 (cholesterol, triglycerides, etc.)
Time frame: Change from baseline assessed at Week 24
Change in quality of life using KDQOL™-36 questionnaire
University Hospital, Martin
Other
Modification of Intestinal Microbiome in Patients With Primary IgA Nephropathy
Acronym: MIMIGA
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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