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Empagliflozin for children and adolescents with chronic kidney disease

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)

Phase 3 Interventional Boehringer Ingelheim · NCT07107945

This trial will test if once-daily empagliflozin tablets help children and teens aged 2–17 with chronic kidney disease and whether they tolerate the medicine well.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment120 (estimated)
Ages2 Years to 17 Years
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Locations102 sites (Birmingham, Alabama and 101 other locations)
Trial IDNCT07107945 on ClinicalTrials.gov

What this trial studies

This randomized, placebo-controlled Phase 3 trial enrolls children aged 2–17 with CKD defined by eGFR 20 to <90 mL/min/1.73 m2 and urine albumin‑creatinine ratio ≥300 mg/g who are on stable standard-of-care therapy. Participants are assigned 2:1 to once-daily empagliflozin or matching placebo for 6 months, after which all participants receive open-label empagliflozin once daily for 12 months. The total participation is about 18 months with roughly 15 in-person visits and at least five phone or video contacts, and repeated blood and urine tests to monitor kidney function, safety, and drug handling. Pharmacokinetics and tolerability in children are measured alongside changes in albuminuria and renal function.

Who should consider this trial

Good fit: Children and adolescents aged 2–17 with CKD who have eGFR between 20 and <90 mL/min/1.73 m2, UACR ≥300 mg/g, are on a stable dose of standard-of-care therapy, and whose parent or guardian can provide consent are ideal candidates.

Not a fit: Children with very low kidney function (eGFR <20), low albuminuria (UACR <300 mg/g), unstable medical conditions, inability to take tablets, or recent changes in standard therapy are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, empagliflozin could slow kidney damage and reduce albuminuria in children with CKD, providing a new treatment option.

How similar studies have performed: Large adult trials of empagliflozin have demonstrated kidney-protective effects, but using empagliflozin in children is largely novel and less tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 101 other locations

+52 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Kidney Disease
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.