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Could a diabetes drug shield Kids' kidneys? new trial launches

NCT ID NCT06430684

Disease control Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Aug 20, 2026 · Updated 3 times

Summary

This early-phase trial aims to see if it's possible to run a study of empagliflozin, a drug already used in adults for kidney disease, in 40 children with chronic kidney disease. Participants are randomly assigned to take the drug or continue usual care for 3 months. Researchers will check if the drug is safe and if it improves blood pressure, urine markers, and heart function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Empagliflozin (a diabetes drug that may protect kidneys and heart)
What this could lead to
If successful, this could pave the way for larger trials testing whether empagliflozin helps slow kidney disease in children.
What could go wrong
This is a very early, small feasibility study with only 40 participants and 3 months of treatment. It is not designed to prove effectiveness, and results may not apply to all children with kidney disease.

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 40 people

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

Started

Aug 2024

Expected to finish

Nov 2026

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

12 to 25 years

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: * Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL/min/1.73m2 Exclusion Criteria: * Heart Disease * Diabetes * Pregnancy * Recipient of solid organ transplant * history of chemotherapy or stem cell transplant * moderate to severe persistent asthma * liver disease * class 2 or greater obesity * inability to follow study procedures due to cognitive impairment * obstructive uropathy or requirement for intermittent urinary catheterization * systolic blood pressure \<100mgHg * orthostatic hypotension * current use of an SGLT2i * anticipated need for titration of anti-hypertensives within 3 months * active use of any immunosuppressive medications * lack of clearance by primary nephrologist for participation

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome kidney disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney diseases Pediatric kidney disease

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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    RECRUITING

    Chicago, Illinois, 60611, United States

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