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Could a diabetes pill protect kids' kidneys? new trial launches

NCT ID NCT07107945

Disease control Sponsor: Boehringer Ingelheim 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Updated 9 times

Summary

This study tests whether empagliflozin, a medicine already used for diabetes, can help children aged 2 to 17 with chronic kidney disease. About 120 kids will take either the drug or a placebo for 6 months, then everyone gets the drug for a year. Researchers will check kidney function and safety through regular visits and tests.

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 120 people

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

Started

Dec 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 17 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: * Signed and dated written informed consent provided by the patient's parent(s) (or legal guardian) and patient's assent in accordance with international council for harmonisation good clinical practice (ICH-GCP) and local legislation prior to admission to the trial (informed assent will be sought according to the patient's age, level of maturity, competence, and capacity). * Age 2 to 17 years at screening Visit 1. * Chronic kidney disease (CKD) of any underlying aetiology defined by (as measured by central laboratory at screening Visit 1): estimated glomerular filtration rate (eGFR) (U25Crea) ≥20 to \<90 mL/min/1.73 m2 with a urine-albumine-creatinine (UACR) ≥300 mg/g * Participants must be on a stable dose of maximally tolerated standard of care (SoC) therapy for 30 days before screening visit 1 with no plans to change the dose throughout the duration of the placebo-controlled duration of the trial. SoC is anticipated to include a single Renin-angiotensin-aldosterone system (RAAS) inhibitor, such as angiotensin receptor blockers (ARB) or angiotensin converting enzyme inhibitors (ACEi) as appropriate and tolerated. Additional use of a mineralocorticoid receptor antagonist (MRA, including finerenone if available) is permitted if needed and the dose is stable for 30 days before screening Visit 1 and no planned dose changes for the placebo-controlled portion of the trial. * Participants receiving daily immunosuppressive therapy for an underlying immunological cause of CKD must be on a stable dose for the duration specified for each drug prior to screening and must remain on a stable regimen throughout the placebo-controlled portion of the trial. * Further inclusion criteria apply. Exclusion Criteria: * Confirmed type 1 or type 2 diabetes mellitus. * History of ketoacidosis within 8 weeks prior to Visit 1 and up to randomisation. * Chronic dialysis or functioning kidney transplant or scheduled for transplantation throughout the duration of the trial. * Diagnosis of uncontrolled metabolic bone disease (at the Investigator's discretion). * Body mass index (BMI) ≤10th percentile for children ≥4 years of age and ≤25th percentile for children \<4 years of age according to Centers for Disease Control and Prevention (CDC) growth chart at screening Visit 1. * Gastrointestinal disorders that might interfere with trial drug absorption according to investigator assessment. * Presence of acute or active urinary tract infection (UTI) with signs or symptoms of an active UTI or therapeutic treatment for an active UTI within 14 days before screening Visit 1. * Severe, uncontrolled hypertension (based on investigator's judgement). * Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome

As listed by the trial registrant

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

Chronic 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

    76 sites in 17 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

  • Alder Hey Children's Hospital

    RECRUITING

    Liverpool, L12 2AP, United Kingdom

  • Amsterdam University Medical Center

    RECRUITING

    Amsterdam, 1105 AZ, Netherlands

  • Ankara Universitesi Tip Fakultesi

    RECRUITING

    Ankara, 06620, Turkey (Türkiye)

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

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Azienda Ospedaliera Universitaria di Padova

    RECRUITING

    Padova, 35128, Italy

  • BC Children's Hospital

    RECRUITING

    Vancouver, British Columbia, V6H 3N1, Canada

  • Birmingham Children's Hospital

    RECRUITING

    Birmingham, B4 6NH, United Kingdom

  • Bristol Royal Hospital for Children

    RECRUITING

    Bristol, BS2 8BJ, United Kingdom

  • CHC Mont Legia

    RECRUITING

    Liège, 4000, Belgium

  • CHUC - Centro Hospitalar e Universitario de Coimbra, EPE

    RECRUITING

    Coimbra, 3000-602, Portugal

  • CHUP, EPE - Centro Materno Infantil do Norte

    RECRUITING

    Porto, 4050-651, Portugal

  • Children's Hospital of Michigan

    COMPLETED

    Detroit, Michigan, 48201, United States

  • Children's Hospital of Philadelphia

    COMPLETED

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Mercy Hospitals and Clinics

    RECRUITING

    Kansas City, Missouri, 64108, United States

  • Chonnam National University Hospital

    RECRUITING

    Gwangju, 61469, South Korea

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Cliniques Universitaires Saint-Luc

    RECRUITING

    Brussels, 1200, Belgium

  • Emory University

    COMPLETED

    Atlanta, Georgia, 30322, United States

  • Equipo Ciencia

    ACTIVE_NOT_RECRUITING

    CABA, C1428BNF, Argentina

  • Erasmus Medisch Centrum

    RECRUITING

    Rotterdam, 3015 GD, Netherlands

  • Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico

    RECRUITING

    Milan, 20122, Italy

  • Great North Children's Hospital

    ACTIVE_NOT_RECRUITING

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • Great Ormond Street Hospital

    RECRUITING

    London, WC1N 3JH, United Kingdom

  • HOP Armand-Trousseau

    RECRUITING

    Paris, 75012, France

  • HOP Enfants et Adolescents

    RECRUITING

    Nantes, 44093, France

  • HOP Timone

    RECRUITING

    Marseille, 13005, France

  • HOP des Enfants

    RECRUITING

    Toulouse, 31059, France

  • HUB CHU Brugmann

    RECRUITING

    Brussels, 1020, Belgium

  • Hacettepe University

    RECRUITING

    Ankara, 06230, Turkey (Türkiye)

  • Hackensack University Medical Center

    COMPLETED

    Hackensack, New Jersey, 07601, United States

  • Hopital Louis Pradel

    RECRUITING

    Bron, 69500, France

  • Hopital Necker

    RECRUITING

    Paris, 75015, France

  • Hospital Italiano de Buenos Aires

    ACTIVE_NOT_RECRUITING

    CABA, C1199ABB, Argentina

  • Hospital Regional Universitario de Malaga

    RECRUITING

    Málaga, 29011, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario de Cruces

    RECRUITING

    Bilbao, 48903, Spain

  • Hospital Virgen del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Hospital de Niños Dr. Ricardo Gutierrez

    ACTIVE_NOT_RECRUITING

    CABA, C1425EFD, Argentina

  • Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Istanbul Capa University

    RECRUITING

    Istanbul, 34093, Turkey (Türkiye)

  • Istituto G. Gaslini

    RECRUITING

    Genova, 16147, Italy

  • Jersey Shore University Medical Center

    RECRUITING

    Neptune City, New Jersey, 07753, United States

  • Jim Pattison Children's Hospital

    RECRUITING

    Saskatoon, Saskatchewan, S7N 0W8, Canada

  • Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • KK Women's and Children's Hospital

    RECRUITING

    Singapore, 229899, Singapore

  • Karolinska University Hospital

    RECRUITING

    Stockholm, 141 86, Sweden

  • Kyungpook National University Hospital

    RECRUITING

    Daegu, 41944, South Korea

  • M Health Fairview Masonic Children's Hospital

    RECRUITING

    Minneapolis, Minnesota, 55454, United States

  • Monash Children's Hospital

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • NIHR Southampton Clinical Research Facility

    RECRUITING

    Southampton, SO16 6YD, United Kingdom

  • National University Hospital

    RECRUITING

    Singapore, 119074, Singapore

  • Nottingham Children's Hospital

    RECRUITING

    Nottingham, NG7 2UH, United Kingdom

  • Novak Center for Children's Health

    COMPLETED

    Louisville, Kentucky, 40202, United States

  • Osmangazi University

    RECRUITING

    Odunpazari, 26040, Turkey (Türkiye)

  • Ospedale Pediatrico Bambino Gesù

    RECRUITING

    Roma, 00165, Italy

  • Primary Children's Hospital

    RECRUITING

    Salt Lake City, Utah, 84113, United States

  • Queen Elizabeth University Hospital

    RECRUITING

    Glasgow, G51 4TF, United Kingdom

  • Queensland Children's Hospital

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

  • Radboud Universitair Medisch Centrum

    RECRUITING

    Nijmegen, 6525 GA, Netherlands

  • Sahlgrenska Universitetssjukhuset, Ostra

    RECRUITING

    Gothenburg, 416 85, Sweden

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

  • Semmelweis University, Faculty of Medicine

    RECRUITING

    Budapest, 1083, Hungary

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam, 13620, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Stanford University School of Medicine

    COMPLETED

    Palo Alto, California, 94304, United States

  • The Children's Hospital at Westmead

    RECRUITING

    Westmead, New South Wales, 2145, Australia

  • The Childrens Memorial Health Institute

    RECRUITING

    Warsaw, 04730, Poland

  • The Hospital for Sick Children

    RECRUITING

    Toronto, Ontario, M5G 1X8, Canada

  • The Royal Children's Hospital

    RECRUITING

    Parkville, Victoria, 3052, Australia

  • ULS de Sao Jose, E.P.E. - Hospital Dona Estefania

    RECRUITING

    Lisbon, 1169-045, Portugal

  • UMC Utrecht

    RECRUITING

    Utrecht, 3584 CX, Netherlands

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Universitair Medisch Centrum Groningen

    RECRUITING

    Groningen, 9713 GZ, Netherlands

  • Universitair Ziekenhuis Gent

    RECRUITING

    Ghent, 9000, Belgium

  • University of Alabama at Birmingham

    COMPLETED

    Birmingham, Alabama, 35233, United States

  • University of Alberta Hospital (University of Alberta)

    RECRUITING

    Edmonton, Alberta, T6G 2B7, Canada

  • University of California Davis

    COMPLETED

    Sacramento, California, 95817, United States

  • University of California San Francisco

    COMPLETED

    San Francisco, California, 94158, United States

  • University of Debrecen Clinical Centre

    RECRUITING

    Debrecen, 4032, Hungary

  • University of Miami

    COMPLETED

    Miami, Florida, 33136, United States

  • University of Michigan

    COMPLETED

    Ann Arbor, Michigan, 48109, United States

  • University of New Mexico

    RECRUITING

    Albuquerque, New Mexico, 87131, United States

  • University of Pecs

    RECRUITING

    Pécs, 7623, Hungary

  • University of Wisconsin

    COMPLETED

    Madison, Wisconsin, 53792, United States

  • Universitätsklinikum Hamburg, Eppendorf

    RECRUITING

    Hamburg, 20246, Germany

  • Universitätsklinikum Heidelberg

    RECRUITING

    Heidelberg, 69120, Germany

  • Universitätsklinikum Köln (AöR)

    RECRUITING

    Cologne, 50937, Germany

  • Universitätsklinikum Tübingen

    RECRUITING

    Tübingen, 72076, Germany

  • Uniwersyteckie Centrum Kliniczne

    RECRUITING

    Gdansk, 80-211, Poland

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Virginia Commonwealth University Health Systems

    COMPLETED

    Richmond, Virginia, 23219, United States

  • Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu

    RECRUITING

    Torun, 87-100, Poland

More trials for these conditions

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