A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)
NCT ID: NCT07107945
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
120 participants
INTERVENTIONAL
2025-12-09
2029-06-25
Brief Summary
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Participants are put into 2 groups randomly, which means by chance. One group takes empagliflozin and the other group takes placebo. Placebo looks like empagliflozin but does not contain any medicine. Participants are twice as likely to be in the empagliflozin group. Participants take empagliflozin or placebo as tablets once a day for 6 months. After 6 months, participants in both groups take empagliflozin as tablets once a day for 1 year.
Participants are in the study for a little over a year and a half. During this time, they visit the study site about 15 times and get at least 5 phone or video calls from the site staff. At the visits, the doctors take blood and urine samples from the participants. The doctors also regularly check participants' health and take note of any unwanted effects.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Empagliflozin treatment arm
Empagliflozin
Empagliflozin
Placebo arm
Placebo
Placebo
Interventions
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Empagliflozin
Empagliflozin
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
2 Years
17 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Stanford University Medical Center
Palo Alto, California, United States
University of California Davis
Sacramento, California, United States
University of California San Francisco
San Francisco, California, United States
University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States
Novak Center for Children's Health
Louisville, Kentucky, United States
Johns Hopkins University
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States
Hackensack Meridian Health
Hackensack, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Hospital Italiano de Buenos Aires
CABA, , Argentina
Hospital de Niños Dr. Ricardo Gutierrez
CABA, , Argentina
Equipo Ciencia
CABA, , Argentina
The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Queensland Children's Hospital
South Brisbane, Queensland, Australia
Monash Children's Hospital
Clayton, Victoria, Australia
The Royal Children's Hospital
Parkville, Victoria, Australia
HUB CHU Brugmann
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
CHC Mont Légia
Liège, , Belgium
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta, Canada
BC Children's Hospital
Vancouver, British Columbia, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
Jim Pattison Children's Hospital
Saskatoon, Saskatchewan, Canada
HOP Louis Pradel
Bron, , France
HOP Timone
Marseille, , France
HOP Enfants et Adolescents
Nantes, , France
HOP Armand-Trousseau
Paris, , France
Hôpital Necker
Paris, , France
HOP des Enfants
Toulouse, , France
Universitätsklinikum Köln (AöR)
Cologne, , Germany
Universitätsklinikum Hamburg, Eppendorf
Hamburg, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Semmelweis University, Faculty of Medicine
Budapest, , Hungary
University of Debrecen Clinical Centre
Debrecen, , Hungary
University of Pecs
Pécs, , Hungary
Istituto G. Gaslini
Genova, , Italy
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliera Universitaria di Padova
Padua, , Italy
Osp. Pediatrico Bambin Gesù
Roma, , Italy
Amsterdam University Medical Center
Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Radboud Universitair Medisch Centrum
Nijmegen, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
University Clinical Center, Gdansk
Gdansk, , Poland
University Children's Hospital in Lublin
Lublin, , Poland
L. Rydygier's Regional Hospital in Torun
Torun, , Poland
The Children's Memorial Health Institute
Warsaw, , Poland
University Clinical Hospital in Wrocław
Wroclaw, , Poland
Centro Hospitais da Universidade de Coimbra
Coimbra, , Portugal
ULS de São José, E.P.E. - Hospital Dona Estefânia
Lisbon, , Portugal
ULS de Santa Maria, E.P.E
Lisbon, , Portugal
CHUP, EPE - Centro Materno Infantil do Norte
Porto, , Portugal
National University Hospital
Singapore, , Singapore
KK Women's and Children's Hospital
Singapore, , Singapore
Kyungpook National University Hospital
Daegu, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Hospital Universitari Vall D Hebron
Barcelona, , Spain
Hospital Universitario de Cruces
Bilbao, , Spain
Hospital Regional Universitario de Málaga
Málaga, , Spain
Hospital Virgen del Rocío
Seville, , Spain
Sahlgrenska Universitetssjukhuset, Östra
Gothenburg, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Hacettepe University
Ankara, , Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi
Ankara, , Turkey (Türkiye)
İstanbul Çapa University
Istanbul, , Turkey (Türkiye)
Osmangazi University
Odunpazari, , Turkey (Türkiye)
Birmingham Children's Hospital
Birmingham, , United Kingdom
Bristol Royal Hospital for Children
Bristol, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Alder Hey Children's Hospital
Liverpool, , United Kingdom
Great Ormond Street Hospital
London, , United Kingdom
Great North Children's Hospital
Newcastle upon Tyne, , United Kingdom
Nottingham Children's Hospital
Nottingham, , United Kingdom
NIHR Southampton Clinical Research Facility
Southampton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Related Info
Other Identifiers
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2024-512577-27-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1312-1389
Identifier Type: REGISTRY
Identifier Source: secondary_id
1245-0256
Identifier Type: -
Identifier Source: org_study_id
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