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

ClinicalTrials.gov ID: NCT07107945

Public ClinicalTrials.gov record NCT07107945. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 13, 2026, 11:54 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07107945
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Boehringer Ingelheim; Industry
Enrollment: 120 participants

Conditions and interventions

Conditions

Chronic Kidney Disease

Interventions

Empagliflozin Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 2 Years to 17 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 8, 2025
Primary completion: Apr 15, 2027
Completion: Apr 13, 2028
Last update posted: Aug 19, 2026

2025 – 2028

United States locations

U.S. sites: 27
U.S. states: 21
U.S. cities: 27

Facility	City	State	ZIP	Site status
University of Alabama at Birmingham	Birmingham	Alabama	35233	Not yet recruiting
Phoenix Children's Hospital	Phoenix	Arizona	85016	Not yet recruiting
University of California Los Angeles	Los Angeles	California	90095	Not yet recruiting
Stanford University School of Medicine	Palo Alto	California	94304	Recruiting
University of California Davis	Sacramento	California	95817	Recruiting
University of California San Francisco	San Francisco	California	94158	Recruiting
University of Miami	Miami	Florida	33136	Not yet recruiting
Emory University	Atlanta	Georgia	30322	Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois	60611	Recruiting
Indiana University	Indianapolis	Indiana	46202	Recruiting
Novak Center for Children's Health	Louisville	Kentucky	40202	Recruiting
Johns Hopkins Hospital	Baltimore	Maryland	21287	Recruiting
University of Michigan	Ann Arbor	Michigan	48109	Recruiting
Children's Hospital of Michigan	Detroit	Michigan	48201	Not yet recruiting
M Health Fairview Masonic Children's Hospital	Minneapolis	Minnesota	55454	Recruiting
Children's Mercy Hospitals and Clinics	Kansas City	Missouri	64108	Recruiting
Hackensack University Medical Center	Hackensack	New Jersey	07601	Recruiting
Jersey Shore University Medical Center	Neptune City	New Jersey	07753	Recruiting
University of New Mexico	Albuquerque	New Mexico	87131	Recruiting
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	45229	Recruiting
Cleveland Clinic	Cleveland	Ohio	44195	Recruiting
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	19104	Not yet recruiting
Vanderbilt University Medical Center	Nashville	Tennessee	37232	Recruiting
Primary Children's Hospital	Salt Lake City	Utah	84113	Recruiting
Virginia Commonwealth University Health Systems	Richmond	Virginia	23219	Recruiting
Seattle Children's Hospital	Seattle	Washington	98105	Recruiting
University of Wisconsin	Madison	Wisconsin	53705-9123	Not yet recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 70 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07107945, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 19, 2026 · Synced Sep 13, 2026

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The complete protocol, eligibility criteria, and contact information for NCT07107945 live on ClinicalTrials.gov.

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