Chronic Kidney DiseasePhase 3NCT07107945
A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)
A Phase 3 study testing Empagliflozin in people with Chronic Kidney Disease, run by Boehringer Ingelheim at 93 sites in 18 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Empagliflozin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 93 sitesin 18 countries
- Study dates
- 9 Dec 2025to 14 Apr 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
93 sites in 18 countries.
93 sites in 18 countries
United States25 sites
University of New Mexico
Albuquerque, New Mexico, 87131
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
Johns Hopkins Hospital
Baltimore, Maryland, 21287
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Cleveland Clinic
Cleveland, Ohio, 44195
Children's Hospital of Michigan
Detroit, Michigan, 48201
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Indiana University
Indianapolis, Indiana, 46202
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
Novak Center for Children's Health
Louisville, Kentucky, 40202
University of Wisconsin
Madison, Wisconsin, 53792
University of Miami
Miami, Florida, 33136
M Health Fairview Masonic Children's Hospital
Minneapolis, Minnesota, 55454
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Stanford University School of Medicine
Palo Alto, California, 94304
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Virginia Commonwealth University Health Systems
Richmond, Virginia, 23219
University of California Davis
Sacramento, California, 95817
Primary Children's Hospital
Salt Lake City, Utah, 84113
University of California San Francisco
San Francisco, California, 94158
Seattle Children's Hospital
Seattle, Washington, 98105
United Kingdom8 sites
Birmingham Children's Hospital
Birmingham, B4 6NH
Bristol Royal Hospital for Children
Bristol, BS2 8DJ
Queen Elizabeth University Hospital
Glasgow, G51 4TF
Alder Hey Children's Hospital
Liverpool, L12 2AP
Great Ormond Street Hospital
London, WC1N 3JH
Great North Children's Hospital
Newcastle upon Tyne, NE1 4LP
Nottingham Children's Hospital
Nottingham, NG7 2UH
NIHR Southampton Clinical Research Facility
Southampton, SO16 6YD
France6 sites
Hopital Louis Pradel
Bron, 69500
HOP Timone
Marseille, 13005
HOP Enfants et Adolescents
Nantes, 44093
HOP Armand-Trousseau
Paris, 75012
Hopital Necker
Paris, 75015
HOP des Enfants
Toulouse, 31059
Belgium5 sites
HUB CHU Brugmann
Brussels, 1020
Cliniques Universitaires Saint-Luc
Brussels, 1200
Universitair Ziekenhuis Gent
Ghent, 9000
UZ Leuven
Leuven, 3000
CHC Mont Legia
Liège, 4000
Netherlands5 sites
Amsterdam University Medical Center
Amsterdam, 1105 AZ
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
Radboud Universitair Medisch Centrum
Nijmegen, 6525 GA
Erasmus Medisch Centrum
Rotterdam, 3015 GD
UMC Utrecht
Utrecht, 3584 CX
Australia4 sites
Monash Children's Hospital
Clayton, Victoria, 3168
The Royal Children's Hospital
Parkville, Victoria, 3052
Queensland Children's Hospital
South Brisbane, Queensland, 4101
The Children's Hospital at Westmead
Westmead, New South Wales, 2145
Canada4 sites
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta, T6G 2B7
Jim Pattison Children's Hospital
Saskatoon, Saskatchewan, S7N 0W8
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
BC Children's Hospital
Vancouver, British Columbia, V6H 3N1
Germany4 sites
Universitätsklinikum Köln (AöR)
Cologne, 50937
Universitätsklinikum Hamburg, Eppendorf
Hamburg, 20246
Universitätsklinikum Heidelberg
Heidelberg, 69120
Universitätsklinikum Tübingen
Tübingen, 72076
Italy4 sites
Istituto G. Gaslini
Genova, 16147
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
Milan, 20122
Azienda Ospedaliera Universitaria di Padova
Padova, 35128
Ospedale Pediatrico Bambino Gesù
Roma, 00165
South Korea4 sites
Kyungpook National University Hospital
Daegu, 41944
Chonnam National University Hospital
Gwangju, 61469
Seoul National University Bundang Hospital
Seongnam, 13620
Seoul National University Hospital
Seoul, 03080
Spain4 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Universitario de Cruces
Bilbao, 48903
Hospital Regional Universitario de Malaga
Málaga, 29011
Hospital Universitario Virgen del Rocio
Seville, 41013
Turkey (Türkiye)4 sites
Hacettepe University
Ankara, 06230
Ankara Universitesi Tip Fakultesi
Ankara, 06620
Istanbul Capa University
Istanbul, 34093
Osmangazi University
Odunpazari, 26040
Argentina3 sites
Hospital Italiano de Buenos Aires
CABA, C1199ABB
Hospital de Niños Dr. Ricardo Gutierrez
CABA, C1425EFD
Equipo Ciencia
CABA, C1428BNF
Hungary3 sites
Semmelweis University, Faculty of Medicine
Budapest, 1083
University of Debrecen Clinical Centre
Debrecen, 4032
University of Pecs
Pécs, 7623
Poland3 sites
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-211
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu
Torun, 87-100
The Childrens Memorial Health Institute
Warsaw, 04730
Portugal3 sites
CHUC - Centro Hospitalar e Universitario de Coimbra, EPE
Coimbra, 3000-602
ULS de Sao Jose, E.P.E. - Hospital Dona Estefania
Lisbon, 1169-045
CHUP, EPE - Centro Materno Infantil do Norte
Porto, 4050-651
Singapore2 sites
National University Hospital
Singapore, 119074
KK Women's and Children's Hospital
Singapore, 229899
Sweden2 sites
Sahlgrenska Universitetssjukhuset, Östra
Gothenburg, 416 85
Karolinska University Hospital
Stockholm, 141 86
About this study
Official title: 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)
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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Empagliflozin, Placebo
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Also called Jardiance
Empagliflozin
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin treatment arm | Experimental | Not described Receives: Drug: Empagliflozin |
| Placebo arm | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Day 1 to the Week 24 visit in urine albumin-creatinine (UACR) [mg/g]
Measured: Up to week 24
Change from Day 1 to the Week 24 visit in urine glucose [mmol/L]
Measured: Up to week 24
Secondary outcomes (5)
Change in estimated glomerular filtration rate (eGFR) (U25Crea) over time during treatment with empagliflozin
U25Crea = estimates the glomerular filtration rate based on creatinine in patients aged up to 25 years
Measured: 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
Measured: Up to week 24
Change from Day 1 to the Week 24 visit in urine protein-creatinine ratio (UPCR)
Measured: Up to week 24
The observed predose plasma concentrations of empagliflozin at the Week 26 visit
Measured: 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)
SAE= serious adverse event AE= adverse event
Measured: Up to week 73
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start9 Dec 2025
- Primary completion16 Apr 2027 (estimated)
- Study completion14 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107945
- Sponsor's protocol ID
- 1245-0256
- Other IDs
- 2024-512577-27-00, U1111-1312-1389
- Status last verified
- Nov 2026
- First submitted
- 5 Aug 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07107945
- Acronym / sponsor ID
- 1245-0256
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 16 Apr 2027 (estimated)
- Study completion
- 14 Apr 2028 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin treatment arm | Experimental | Drug: Empagliflozin |
| Placebo arm | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmpagliflozinAlso: JardianceEmpagliflozin | Drug | Empagliflozin treatment arm |
| PlaceboPlacebo | Drug | Placebo arm |
Primary outcome
Change from Day 1 to the Week 24 visit in urine albumin-creatinine (UACR) [mg/g]
Time frame: Up to week 24
Change from Day 1 to the Week 24 visit in urine glucose [mmol/L]
Time frame: Up to week 24
5 secondary outcomes
Change in estimated glomerular filtration rate (eGFR) (U25Crea) over time during treatment with empagliflozin
Time frame: 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
Time frame: Up to week 24
Change from Day 1 to the Week 24 visit in urine protein-creatinine ratio (UPCR)
Time frame: Up to week 24
The observed predose plasma concentrations of empagliflozin at the Week 26 visit
Time frame: 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)
Time frame: Up to week 73
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Chronic Kidney Disease
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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
93 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Empagliflozin in people with Chronic Kidney Disease, run by Boehringer Ingelheim at 93 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites in United States, United Kingdom, France, Belgium, Netherlands and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Day 1 to the Week 24 visit in urine albumin-creatinine (UACR) [mg/g] (time frame: Up to week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.