Can a gut metabolite shield the kidneys in IgA nephropathy?
NCT ID NCT07750249
First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This trial tests whether sodium butyrate, a short-chain fatty acid, can reduce protein in the urine and slow kidney function decline in people with IgA nephropathy, a kidney disease. Participants receive either sodium butyrate or a placebo for 12 weeks, then switch after a washout period. The study aims to see if changing the gut microbiome can help manage the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sodium butyrate (a short-chain fatty acid) taken as an oral capsule
- What this could lead to
- If it works, this could offer a safe, cost-effective way to slow kidney damage in IgA nephropathy, potentially delaying the need for more aggressive treatments.
- What could go wrong
- This is an early-phase trial, so the benefits are uncertain. The study is relatively small, and sodium butyrate may cause gastrointestinal side effects or may not significantly reduce proteinuria.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Hospital Martin
Martin, 036 01, Slovakia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New drug aims to protect kidneys in IgA nephropathy patients
- New drug aims to reduce kidney damage in IgAN patients