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

Launched by BOEHRINGER INGELHEIM · Aug 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a medicine called empagliflozin can help children and teenagers aged 2 to 17 who have chronic kidney disease (CKD), a condition where the kidneys do not work as well as they should. The study also wants to see how well the medicine is tolerated and how the body processes it in young patients. Children who join the trial will be randomly placed into two groups: one group will take empagliflozin, and the other will take a placebo—a pill that looks like the medicine but has no active drug. Twice as many children will receive empagliflozin as placebo. After six months, everyone will take empagliflozin for another year.

To join the study, children must have CKD with certain kidney function levels and have been on stable treatment for their kidney condition for at least 30 days. Kids with type 1 diabetes, recent serious infections, or those on dialysis or with a kidney transplant are not eligible. During the study, participants will visit the clinic about 15 times and have at least five phone or video check-ins over roughly 18 months. Doctors will take blood and urine samples and monitor their health closely to watch for any side effects. This study is not yet recruiting, but it aims to better understand if empagliflozin is a safe and helpful treatment option for children with CKD.

Gender

ALL

Eligibility 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
• • Stable standard of care (SoC) CKD treatment for 30 days prior to randomisation with no plans to modify the dose during the trial, at the discretion of the investigator. 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. Additional use of a mineralocorticoid receptor antagonist (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
• • Participants on daily immunosuppressive medication to treat an underlying immunologic cause of CKD must be on a stable dose for 30 days before screening Visit 1 and until randomisation Visit 2. Participants who are taking rituximab or cyclophosphamide should have last taken a dose ≥120 days before screening Visit 1.
• • Further inclusion criteria apply.
• Exclusion Criteria:
• • Confirmed type 1 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.