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Can a gut metabolite shield the kidneys in IgA nephropathy?

NCT ID NCT07750249

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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.

    Open the record ↗

  3. 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

  • University Hospital Martin

    Martin, 036 01, Slovakia

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