A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)
A Randomised, Double-blind, Placebo-controlled Trial With an Open-label Extension to Assess the Pharmacokinetics, Safety, and Efficacy of Empagliflozin Tablets in Paediatric Patients With Chronic Kidney Disease (EMPA-KIDNEY® Kids)
3 other identifiers
interventional
120
18 countries
102
Brief Summary
This study is open to children aged 2 to 17 with chronic kidney disease (CKD). The purpose of this study is to find out if a medicine called empagliflozin helps children and adolescents with CKD. Other goals of the study are to find out how empagliflozin is tolerated and handled by the body in children and adolescents with CKD. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2025
Typical duration for phase_3
102 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2025
CompletedFirst Posted
Study publicly available on registry
August 6, 2025
CompletedStudy Start
First participant enrolled
December 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 25, 2029
April 15, 2026
April 1, 2026
2.5 years
August 5, 2025
April 14, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Change from Day 1 to the Week 24 visit in urine albumin-creatinine (UACR) [mg/g]
Up to week 24
Change from Day 1 to the Week 24 visit in urine glucose [mmol/L]
Up to week 24
Secondary Outcomes (5)
Change in estimated glomerular filtration rate (eGFR) (U25Crea) over time during treatment with empagliflozin
Up to week 73
Annual rate of change in eGFR (U25Crea) from the Week 8 to the Week 24 visit, including treatment effect extrapolation from (adult) EMPA-KIDNEY data
Up to week 24
Change from Day 1 to the Week 24 visit in urine protein-creatinine ratio (UPCR)
Up to week 24
The observed predose plasma concentrations of empagliflozin at the Week 26 visit
Up to week 26
Occurrence of at least one SAE or AE of special interest (AESI) per participant between Day 1 and the Week 24 visit, and between the Week 24 visit and end of treatment (EoT) +7 days residual effect period (REP)
Up to week 73
Study Arms (2)
Empagliflozin treatment arm
EXPERIMENTALPlacebo arm
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (102)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
University of California Los Angeles
Los Angeles, California, 90095, United States
Stanford University Medical Center
Palo Alto, California, 94301, United States
University of California Davis
Sacramento, California, 95817, United States
University of California San Francisco
San Francisco, California, 94158, United States
University of Miami
Miami, Florida, 33136, United States
Emory University
Atlanta, Georgia, 30322, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Novak Center for Children's Health
Louisville, Kentucky, 40202, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
M Health Fairview Masonic Children's Hospital
Minneapolis, Minnesota, 55454, United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108, United States
Hackensack Meridian Health
Hackensack, New Jersey, 07601, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75235, United States
Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
Virginia Commonwealth University Health Systems
Richmond, Virginia, 23219, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
University of Wisconsin
Madison, Wisconsin, 53705-9123, United States
Hospital Italiano de Buenos Aires
CABA, C1199ABB, Argentina
Hospital de Niños Dr. Ricardo Gutierrez
CABA, C1425EFD, Argentina
Equipo Ciencia
CABA, C1428BNF, Argentina
The Children's Hospital at Westmead
Westmead, New South Wales, 2145, Australia
Queensland Children's Hospital
South Brisbane, Queensland, 4101, Australia
Monash Children's Hospital
Clayton, Victoria, 3168, Australia
The Royal Children's Hospital
Parkville, Victoria, 3052, Australia
HUB CHU Brugmann
Brussels, 1020, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHC Mont Légia
Liège, 4000, Belgium
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta, T6G 2B7, Canada
BC Children's Hospital
Vancouver, British Columbia, V6H 3N1, Canada
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, H4A 3J1, Canada
Jim Pattison Children's Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Hôpital Louis Pradel
Bron, 69500, France
HOP Timone
Marseille, 13005, France
HOP Enfants et Adolescents
Nantes, 44093, France
HOP Armand-Trousseau
Paris, 75012, France
Hôpital Necker
Paris, 75015, France
HOP des Enfants
Toulouse, 31059, France
Universitätsklinikum Köln (AöR)
Cologne, 50937, Germany
Universitätsklinikum Hamburg, Eppendorf
Hamburg, 20246, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
Semmelweis University, Faculty of Medicine
Budapest, 1083, Hungary
University of Debrecen Clinical Centre
Debrecen, 4032, Hungary
University of Pecs
Pécs, 7623, Hungary
Istituto G. Gaslini
Genova, 16147, Italy
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
Milan, 20122, Italy
Azienda Ospedaliera Universitaria di Padova
Padova, 35128, Italy
Osp. Pediatrico Bambin Gesù
Roma, 00165, Italy
Amsterdam University Medical Center
Amsterdam, 1105 AZ, Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, Netherlands
Radboud Universitair Medisch Centrum
Nijmegen, 6525 GA, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 GD, Netherlands
UMC Utrecht
Utrecht, 3584 CX, Netherlands
University Clinical Center, Gdansk
Gdansk, 80-211, Poland
University Children's Hospital in Lublin
Lublin, 20-093, Poland
L. Rydygier's Regional Hospital in Torun
Torun, 87-100, Poland
The Children's Memorial Health Institute
Warsaw, 04730, Poland
University Clinical Hospital in Wrocław
Wroclaw, 50 556, Poland
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, 3000-602, Portugal
ULS de São José, E.P.E. - Hospital Dona Estefânia
Lisbon, 1169-045, Portugal
ULS de Santa Maria, E.P.E
Lisbon, 1600-190, Portugal
CHUP, EPE - Centro Materno Infantil do Norte
Porto, 4050-651, Portugal
National University Hospital
Singapore, 119074, Singapore
KK Women's and Children's Hospital
Singapore, 229899, Singapore
Kyungpook National University Hospital
Daegu, 41944, South Korea
Chonnam National University Hospital
Gwangju, 61469, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario de Cruces
Bilbao, 48903, Spain
Hospital Regional Universitario de Málaga
Málaga, 29011, Spain
Hospital Virgen del Rocío
Seville, 41013, Spain
Sahlgrenska Universitetssjukhuset, Östra
Gothenburg, 416 85, Sweden
Karolinska University Hospital
Stockholm, 141 86, Sweden
Hacettepe University
Ankara, 06230, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi
Ankara, 06620, Turkey (Türkiye)
İstanbul Çapa University
Istanbul, 34093, Turkey (Türkiye)
Osmangazi University
Odunpazari, 26040, Turkey (Türkiye)
Birmingham Children's Hospital
Birmingham, B4 6NH, United Kingdom
Bristol Royal Hospital for Children
Bristol, BS2 8BJ, United Kingdom
Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
Alder Hey Children's Hospital
Liverpool, L12 2AP, United Kingdom
Great Ormond Street Hospital
London, WC1N 3JH, United Kingdom
Great North Children's Hospital
Newcastle upon Tyne, NE1 4LP, United Kingdom
Nottingham Children's Hospital
Nottingham, NG7 2UH, United Kingdom
NIHR Southampton Clinical Research Facility
Southampton, SO16 6YD, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2025
First Posted
August 6, 2025
Study Start
December 9, 2025
Primary Completion (Estimated)
June 26, 2028
Study Completion (Estimated)
June 25, 2029
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
- Access Criteria
- For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.