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New hope for kidney stone sufferers: drug and diet combo tested in major trial

NCT ID NCT06653738

Disease control Sponsor: Insel Gruppe AG, University Hospital Bern 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 04, 2026 · Updated 4 times

Summary

This study tests two approaches to prevent kidney stones from coming back in people who have had them before. One approach uses a daily pill called empagliflozin (a diabetes drug) and the other gives personalized diet advice based on urine tests. The trial will involve 400 adults with calcium-based kidney stones and will last 3 years.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 400 people

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

Started

Jul 2026

Expected to finish

Sep 2030

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: 1. Written, informed consent. 2. Age 18 years or older. 3. Recurrent kidney stone disease with 2 or more stone episodes in the last 10 years prior to randomization. 4. Last kidney stone containing 50% or more of CaOx, CaP or a mixture of both. 5. If taking guideline-recommended medications for kidney stone prophylaxis (e.g. citrate salts), patients must have been on a stable regimen for at least 60 days before randomization and willing to remain on this stable regimen for the duration of the study. Exclusion criteria: 1. Known history of secondary or Mendelian causes of calcium nephrolithiasis 2. Type I diabetes mellitus 3. History of ketoacidosis 4. Chronic Kidney Disease (CKD) stage 4 or 5 (defined as CKD-EPI eGFR \<30 mL/min) 5. Kidney transplant recipient 6. History of recurrent urinary tract infections, defined as \>3 episodes within the year prior to randomization 7. Heart failure. Symptomatic patients with suspected heart failure must be evaluated before study enrollment 8. Treatment with an SGLT2i within 4 weeks prior to randomization. 9. Active cancer treatment 10. Pregnancy and/or breastfeeding. Women of childbearing potential (i.e., premenopausal women who have not undergone surgical sterilization and are sexually active with a male partner) must have a negative urine or blood pregnancy test prior to enrollment 11. Known allergy to the study drug 12. Inability to understand and follow the study procedures 13. Vulnerable individual, e.g. individual incapable of judgement or currently incarcerated or otherwise institutionalized (priosner), or refugee 14. Concomitant participation in another interventional clinical trial within 4 weeks prior to randomization and during the current trial 15. Prior enrollment in the EMPASTONE trial

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Conditions

The condition(s) this trial relates to.

Kidney Calculi nephrolithiasis

As listed by the trial registrant

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

Dietary exposure Kidney stone Nephrolithiasis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites in 4 countries. 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

  • Charité University Medicine Berlin

    NOT_YET_RECRUITING

    Berlin, 10117, Germany

  • Hôpital Européen Georges Pompidou

    NOT_YET_RECRUITING

    Paris, 75908, France

  • Hôpital Tenon

    NOT_YET_RECRUITING

    Paris, 75020, France

  • Inselspital Bern

    RECRUITING

    Bern, 3010, Switzerland

  • Kantonsspital Aarau

    NOT_YET_RECRUITING

    Aarau, 5001, Switzerland

  • Kantonsspital Baden

    NOT_YET_RECRUITING

    Baden, 5404, Switzerland

  • Kantonsspital Chur

    NOT_YET_RECRUITING

    Chur, 7000, Switzerland

  • Kantonsspital Fribourg

    NOT_YET_RECRUITING

    Fribourg, 1708, Switzerland

  • Kantonsspital Luzern

    NOT_YET_RECRUITING

    Lucerne, 6016, Switzerland

  • Kantonsspital Neuchâtel

    NOT_YET_RECRUITING

    Neuchâtel, 2000, Switzerland

  • Kantonsspital Olten

    NOT_YET_RECRUITING

    Olten, 4600, Switzerland

  • Kantonsspital Sion

    NOT_YET_RECRUITING

    Sion, 1950, Switzerland

  • Kantonsspital St. Gallen

    NOT_YET_RECRUITING

    Sankt Gallen, 9007, Switzerland

  • Lausanne University Hospital (CHUV)

    NOT_YET_RECRUITING

    Lausanne, 1011, Switzerland

  • Regionalspital Lugano

    NOT_YET_RECRUITING

    Lugano, 6900, Switzerland

  • University Hospital Amiens-Picardie

    NOT_YET_RECRUITING

    Amiens, 80054, France

  • University Hospital Basel

    NOT_YET_RECRUITING

    Basel, 4031, Switzerland

  • University Hospital Geneva (HUG)

    NOT_YET_RECRUITING

    Geneva, 1211, Switzerland

  • Università della Campania "Luigi Vanvitelli"

    NOT_YET_RECRUITING

    Naples, 80131, Italy

  • Universitätsspital Zürich

    NOT_YET_RECRUITING

    Zurich, 8091, Switzerland

  • Verona University Hospital

    NOT_YET_RECRUITING

    Verona, 37134, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.