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Active, not recruiting Phase 3 Interventional

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.

ClinicalTrials.gov public records Last synced Nov 9, 2026, 11:52 AM EST

All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. 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
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
135 participants

Conditions and interventions

Interventions

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 9, 2025 (Actual)
Primary completion
Apr 16, 2027 (Estimated)
Completion
Apr 14, 2028 (Estimated)
Last update posted
Nov 5, 2026

2025 – 2028

United States locations

U.S. sites
25
U.S. states
20
U.S. cities
25
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35233 —
Stanford University School of Medicine Palo Alto California 94304 —
University of California Davis Sacramento California 95817 —
University of California San Francisco San Francisco California 94158 —
University of Miami Miami Florida 33136 —
Emory University Atlanta Georgia 30322 —
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois 60611 —
Indiana University Indianapolis Indiana 46202 —
Novak Center for Children's Health Louisville Kentucky 40202 —
Johns Hopkins Hospital Baltimore Maryland 21287 —
University of Michigan Ann Arbor Michigan 48109 —
Children's Hospital of Michigan Detroit Michigan 48201 —
M Health Fairview Masonic Children's Hospital Minneapolis Minnesota 55454 —
Children's Mercy Hospitals and Clinics Kansas City Missouri 64108 —
Hackensack University Medical Center Hackensack New Jersey 07601 —
Jersey Shore University Medical Center Neptune City New Jersey 07753 —
University of New Mexico Albuquerque New Mexico 87131 —
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 —
Cleveland Clinic Cleveland Ohio 44195 —
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
Vanderbilt University Medical Center Nashville Tennessee 37232 —
Primary Children's Hospital Salt Lake City Utah 84113 —
Virginia Commonwealth University Health Systems Richmond Virginia 23219 —
Seattle Children's Hospital Seattle Washington 98105 —
University of Wisconsin Madison Wisconsin 53792 —

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 68 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 Nov 5, 2026 · Synced Nov 9, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07107945 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →