A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)
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)
Sponsor: Boehringer Ingelheim
This observational or N/A phase trial investigates Chronic Kidney Disease and is currently actively recruiting participants. Boehringer Ingelheim leads this study, which shows 9 recorded versions since 2025 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
9 versions recorded-
May 4, 2026 — Present [daily]
Recruiting
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Apr 16, 2026 — May 4, 2026 [daily]
Recruiting
Phase: PHASE3 → None
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Mar 2026 — Apr 2026 [monthly]
Recruiting PHASE3
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Feb 2026 — Mar 2026 [monthly]
Recruiting PHASE3
-
Jan 2026 — Feb 2026 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
▶ Show 4 earlier versions
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Dec 2025 — Jan 2026 [monthly]
Not Yet Recruiting PHASE3
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Nov 2025 — Dec 2025 [monthly]
Not Yet Recruiting PHASE3
-
Oct 2025 — Nov 2025 [monthly]
Not Yet Recruiting PHASE3
-
Sep 2025 — Oct 2025 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility 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.
Contact Information
- Boehringer Ingelheim
For direct contact, visit the study record on ClinicalTrials.gov .