Clinical Trial

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

Recruiting Phase 3
View on ClinicalTrials.gov →
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. 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.
Protocol Amendment History 2 changes
notable Primary completion moved earlier: 2028-06-26 -> 2027-04-16 2026-07-28
minor Completion moved earlier: 2029-06-25 -> 2028-04-14 2026-07-28
Trial Details
NCT Number NCT07107945
Lead Sponsor Boehringer Ingelheim
Conditions Chronic Kidney Disease
Enrollment 120 participants
Start Date 2025-12-09
Primary Completion 2027-04-16 (estimated)
Study Completion 2028-04-14 (estimated)
Updated on ClinicalTrials.gov 2026-08-07