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Clinical Trials in the USA / NCT07107945
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 · tracked via the Priya Life Science USA tracker
Sponsor
Boehringer Ingelheim
Phase
Phase 3
Started
2025-12-09
Last updated
2026-09-16

Condition(s) studied

Chronic Kidney Disease

Investigational drug(s) / intervention(s)

EmpagliflozinPlacebo

Empagliflozin: Empagliflozin

Placebo: Placebo

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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * Signed and dated written informed consent provided by the patient's parent(s) (or legal guardian) and patient's assent in accordance with international council for harmonisation good clinical practice (ICH-GCP) and local legislation prior to admission to the trial (informed assent will be sought according to the patient's age, level of maturity, competence, and capacity). * Age 2 to 17 years at screening Visit 1. * Chronic kidney disease (CKD) of any underlying aetiology defined by (as measured by central laboratory at screening Visit 1): estimated glomerular filtration rate (eGFR) (U25Crea) ≥20 to \<90 mL/min/1.73 m2 with a urine-albumine-creatinine (UACR) ≥300 mg/g * Participants must be on a stable dose of maximally tolerated standard of care (SoC) therapy for 30 days before screening visit 1 with no plans to change the dose throughout the duration of the placebo-controlled duration of the trial. SoC is anticipated to include a single Renin-angiotensin-aldosterone system (RAAS) inhibitor, such as angiotensin receptor blockers (ARB) or angiotensin converting enzyme inhibitors (ACEi) as appropriate and tolerated. Additional use of a mineralocorticoid receptor antagonist (MRA, including finerenone if available) is permitted if needed and the dose is stable for 30 days before screening Visit 1 and no planned dose changes for the placebo-controlled portion of the trial. * Participants receiving daily immunosuppressive therapy for an underlying immunological cause of CKD must be on a stable dose for the duration specified for each drug prior to screening and must remain on a stable regimen throughout the placebo-controlled portion of the trial. * Further inclusion criteria apply. Exclusion Criteria: * Confirmed type 1 or type 2 diabetes mellitus. * History of ketoacidosis within 8 weeks prior to Visit 1 and up to randomisation. * Chronic dialysis or functioning kidney transplant or scheduled for transplantation throughout the duration of the trial. * Diagnosis of uncontrolled metabolic bone disease (at the Investigator's discretion). * Body mass index (BMI) ≤10th percentile for children ≥4 years of age and ≤25th percentile for children \<4 years of age according to Centers for Disease Control and Prevention (CDC) growth chart at screening Visit 1. * Gastrointestinal disorders that might interfere with trial drug absorption according to investigator assessment. * Presence of acute or active urinary tract infection (UTI) with signs or symptoms of an active UTI or therapeutic treatment for an active UTI within 14 days before screening Visit 1. * Severe, uncontrolled hypertension (based on investigator's judgement). * Further exclusion criteria apply.

Primary outcome measure(s)

Trial sites (93)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Completed
Stanford University School of Medicine Palo Alto California Completed
University of California Davis Sacramento California Completed
University of California San Francisco San Francisco California Completed
University of Miami Miami Florida Completed
Emory University Atlanta Georgia Completed
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois Recruiting
Indiana University Indianapolis Indiana Recruiting
Novak Center for Children's Health Louisville Kentucky Completed
Johns Hopkins Hospital Baltimore Maryland Recruiting
University of Michigan Ann Arbor Michigan Completed
Children's Hospital of Michigan Detroit Michigan Completed
M Health Fairview Masonic Children's Hospital Minneapolis Minnesota Recruiting
Children's Mercy Hospitals and Clinics Kansas City Missouri Recruiting
Hackensack University Medical Center Hackensack New Jersey Completed
Jersey Shore University Medical Center Neptune City New Jersey Recruiting
University of New Mexico Albuquerque New Mexico Recruiting
Cincinnati Children's Hospital Medical Center Cincinnati Ohio Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
Children's Hospital of Philadelphia Philadelphia Pennsylvania Completed
Vanderbilt University Medical Center Nashville Tennessee Recruiting
Primary Children's Hospital Salt Lake City Utah Recruiting
Virginia Commonwealth University Health Systems Richmond Virginia Completed
Seattle Children's Hospital Seattle Washington Recruiting
University of Wisconsin Madison Wisconsin Completed
Hospital Italiano de Buenos Aires CABA Argentina Active Not Recruiting
Hospital de Niños Dr. Ricardo Gutierrez CABA Argentina Active Not Recruiting
Equipo Ciencia CABA Argentina Active Not Recruiting
The Children's Hospital at Westmead Westmead New South Wales Recruiting
Queensland Children's Hospital South Brisbane Queensland Recruiting
Monash Children's Hospital Clayton Victoria Recruiting
The Royal Children's Hospital Parkville Victoria Recruiting
HUB CHU Brugmann Brussels Belgium Recruiting
Cliniques Universitaires Saint-Luc Brussels Belgium Recruiting
Universitair Ziekenhuis Gent Ghent Belgium Recruiting
UZ Leuven Leuven Belgium Recruiting
CHC Mont Legia Liège Belgium Recruiting
University of Alberta Hospital (University of Alberta) Edmonton Alberta Recruiting
BC Children's Hospital Vancouver British Columbia Recruiting
The Hospital for Sick Children Toronto Ontario Recruiting

+ 53 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07107945 on ClinicalTrials.gov ↗ ← All trials in the USA