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During the congress, E-Posters will be accessible to all participants on the congress website 24/7, as well as in the E-poster stations in the congress center.
Preparing your E-Poster
Please review the E-Poster format requirements carefully when preparing your E-Poster. Should your E-Poster not meet the mentioned requirements, it may not be displayed as described above.
E-Poster Submission Deadline
Please prepare and upload your E-Poster no later than March 14, 2026 11.59PM CET. After this date, you will no longer be able to prepare and upload your E-poster and it will not be displayed and accessible on the congress website.
Please follow the instructions below to input your abstract title.
Abstract titles should be brief and reflect the content of the abstract.
To describe the design of the EMPA-KIDNEY KIDS randomised controlled trial (RCT), which will evaluate the pharmacokinetics (PK), safety, and efficacy of oral empagliflozin in children with chronic kidney disease (CKD) at increased risk of progression.
This randomised, double-blind, parallel-group, 2-arm, multicentre, international Phase III RCT will include a 4-week screening period, a 24-week double-blind placebo-controlled period, and a 48-week open-label period in which all participants will receive empagliflozin.
Eligibility criteria include age 2-17 years and CKD of any aetiology deemed to be at increased risk of progression, estimated glomerular filtration rate [eGFR] 20-90 mL/min/1.73 m2 determined using the U25 equation based on creatinine, and urine albumin-creatinine ratio [UACR] ≥300 mg/g. Participants will be randomised 2:1 to once daily empagliflozin or placebo in addition to standard of care. Empagliflozin dosing will be weight-based:10mg (>50kg); 5mg (20kg-50 kg) and 2.5 mg (<20 kg).
The primary endpoint is a “primary endpoint family” with two members: absolute change in UACR and absolute change in urine glucose, each from Day 1 to Week 24. Secondary outcomes include changes in eGFR, urine protein-creatinine ratio, PK, and safety assessments. Urinary biomarkers and plasma empagliflozin concentrations (pre- and post-dose) will also be assessed. Vital signs, including home weight measurements to monitor fluid status, will be monitored.
Primary and final analyses will occur after the randomised and open-label periods, respectively. Primary outcomes will be assessed using mixed-model repeated measures. Subgroup analyses of efficacy endpoints by disease aetiology (glomerular vs non-glomerular) are also planned.
The target sample is 120 participants (80 empagliflozin and 40 placebo). The statistical power for the primary endpoint family is >90% with an assumed geometric mean (gmean) ratio of 0.78 for change from Day 1 to Week 24 in UACR, and a mean difference of 57 mmol/L for change from Day 1 to Week 24 in urine glucose.
EMPA-KIDNEY Kids is the first study to provide high-quality PK, safety, and efficacy data for the SGLT2 inhibitor empagliflozin in children aged 2-17 years with the full spectrum of CKD who are at increased risk of disease progression. Global enrolment is planned to begin in 19 countries in November 2025.
Previously presented at the 57th European Society for Paediatric Nephrology Annual Meeting, Athens, Greece, 15–18 October 2025.