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Could a common diabetes drug stop kidney stones before they start?

NCT ID NCT07055282

Prevention Sponsor: University of Chicago Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This study tests whether empagliflozin, a drug used for diabetes and heart conditions, can help prevent calcium-based kidney stones. Researchers will give the drug daily for 4 weeks to 32 adults who have had calcium oxalate or calcium phosphate stones. They will measure changes in urine chemistry that affect stone formation. The goal is to see if this drug could be a new prevention strategy for kidney stones.

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 32 people

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

Started

Nov 2025

Expected to finish

Nov 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 to 70 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: Calcium phosphate (CaP) stone participants: * Age 18-70 * History of at least one calcium phosphate (hydroxyapatite) stone * Defined as at least 50% of stone material on most recent stone analysis Calcium oxalate (CaOx) stone participants: * Age 18-70 * History of at least one calcium oxalate stone * Defined as at least 50% of stone material on most recent stone analysis. Other inclusion criteria considerations: The investigators will study balanced numbers of male and females. Prior studies did not have balanced representation of male and female sexes. In prior studies, less than 40% were female, or sex data is not presented. Study of both male and female sex is crucial with kidney stones and therapies that affect citrate and pH because there are well established epidemiologic differences in stone type and physiologic differences in acid-base handling by sex. Epidemiologically, younger women are more likely to have CaP stones, and this is likely because they have higher urine pH. Exclusion Criteria: * History of primarily brushite, uric acid, cysteine, or struvite stones * History of severe acid-base abnormality, very low (less than 100mg/day) or very high (greater than 1500mg/day) urine citrate * Participants who cannot stop diuretic medication or alkali supplementation for the course of the study period * Use of drugs that can directly affect proximal tubule function (e.g., topiramate) * Diagnosis of complete distal renal tubular acidosis * Diagnosis of chronic kidney disease (eGFR \<60 mL/min/1.73m²)

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Conditions

The condition(s) this trial relates to.

Kidney Calculi nephrolithiasis nephrolithiasis, calcium oxalate

As listed by the trial registrant

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

Kidney stones

How to take part

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  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

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

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