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EMPA-KIDNEY® Kids: Empagliflozin for Children with Chronic Kidney Disease

This study is looking at empagliflozin, a medicine, to see if it helps children and adolescents aged 2 to 17 who have chronic kidney disease (CKD). We want to understand how well empagliflozin is tolerated and how it works in their bodies. Participants will be randomly assigned to receive either empagliflozin or a placebo (a pill with no medicine) for 6 months. After that, everyone will receive empagliflozin for another year. We will measure changes in urine albumin-creatinine (UACR) and urine glucose to see if the treatment is successful. The study aims to enroll 120 participants.

Study design
This is an interventional study where participants are randomly assigned to one of two groups. One group receives empagliflozin, and the other receives a placebo, with twice as many participants receiving empagliflozin.
What's involved
Participants will take empagliflozin or placebo tablets once a day for 6 months, followed by empagliflozin tablets once a day for 1 year. Measurements will be taken up to Week 24.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for changes in urine measurements up to Week 24.

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NCT07107945

A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)

Recruiting
PHASE3Ages 2–17InterventionalTreatment
Boehringer Ingelheim
~120 participants
Updated 2026-09-16 on ClinicalTrials.gov
What's tested:EmpagliflozinPlacebo

At a glance

Recruiting sites
76 of 93 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Day 1 to the Week 24 visit in urine albumin-creatinine (UACR) [mg/g]
Measured over Up to week 24
+1 more outcome measured

Conditions

Chronic Kidney Disease

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NCT07107945

Where you'd take part

This study runs at 93 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Alder Hey Children's Hospital

    Liverpool, United Kingdomstudy coordinator listed

    Recruiting

  • Amsterdam University Medical Center

    Amsterdam, Netherlandsstudy coordinator listed

    Recruiting

  • Ankara Universitesi Tip Fakultesi

    Ankara, Turkey (Türkiye)study coordinator listed

    Recruiting

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

    Chicago, Illinoisstudy coordinator listed

    Recruiting

  • Azienda Ospedaliera Universitaria di Padova

    Padova, Italystudy coordinator listed

    Recruiting

  • BC Children's Hospital

    Vancouver, British Columbia, Canadastudy coordinator listed

    Recruiting

  • Birmingham Children's Hospital

    Birmingham, United Kingdomstudy coordinator listed

    Recruiting

  • Bristol Royal Hospital for Children

    Bristol, United Kingdomstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Boehringer Ingelheim
[email protected]
1-800-243-0127
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

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).

What this trial measures

  • 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