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RECRUITING Phase 3

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

NCT07107945 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Empagliflozin

Study Locations (20)

California

  • University of California Los Angeles — Los Angeles
  • Stanford University Medical Center — Palo Alto
  • University of California Davis — Sacramento
  • University of California San Francisco — San Francisco

Michigan

  • University of Michigan — Ann Arbor
  • Children's Hospital of Michigan — Detroit

New Jersey

  • Hackensack Meridian Health — Hackensack
  • Jersey Shore University Medical Center — Neptune City

Alabama

  • University of Alabama at Birmingham — Birmingham

Arizona

  • Phoenix Children's Hospital — Phoenix

Florida

  • University of Miami — Miami

Georgia

  • Emory University — Atlanta

Illinois

  • Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2025-12-09
Est. Completion 2029-06-25
Phase Phase 3

Sponsor

Boehringer Ingelheim

203 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07107945

The ClinicalTrials.gov registry entry for NCT07107945 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Chronic Kidney Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07107945 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Michigan, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07107945 about?

NCT07107945 is a clinical study titled "A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)". 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 child...

What is the current status of trial NCT07107945?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2025-12-09. Estimated completion is 2029-06-25.

What conditions does trial NCT07107945 study?

This clinical trial studies the following conditions: Chronic Kidney Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07107945?

The interventions under investigation include: Placebo (DRUG), Empagliflozin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07107945?

This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07107945 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial