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NCT07107945PHASE3Recruiting

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

Boehringer Ingelheim

Start Date

12/9/2025

Completion Date

4/14/2028

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 Criteria

Age Range: 2 years to 17 years

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.

Interventions

DRUG

Empagliflozin

DRUG

Placebo

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Conditions

Chronic Kidney Disease

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35233

United States

Phoenix Children's Hospital

Phoenix, Arizona 85016

United States

University of California Los Angeles

Los Angeles, California 90095

United States

Stanford University School of Medicine

Palo Alto, California 94304

United States

University of California Davis

Sacramento, California 95817

United States

University of California San Francisco

San Francisco, California 94158

United States

University of Miami

Miami, Florida 33136

United States

Emory University

Atlanta, Georgia 30322

United States

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

Chicago, Illinois 60611

United States

Indiana University

Indianapolis, Indiana 46202

United States

Novak Center for Children's Health

Louisville, Kentucky 40202

United States

Johns Hopkins Hospital

Baltimore, Maryland 21287

United States

Boston Children's Hospital

Boston, Massachusetts 02115

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

Children's Hospital of Michigan

Detroit, Michigan 48201

United States

M Health Fairview Masonic Children's Hospital

Minneapolis, Minnesota 55454

United States

Children's Mercy Hospitals and Clinics

Kansas City, Missouri 64108

United States

Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Jersey Shore University Medical Center

Neptune City, New Jersey 07753

United States

University of New Mexico

Albuquerque, New Mexico 87131

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45229

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Nationwide Children's Hospital

Columbus, Ohio 43205

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

University of Texas Southwestern Medical Center

Dallas, Texas 75235

United States

Primary Children's Hospital

Salt Lake City, Utah 84113

United States

Virginia Commonwealth University Health Systems

Richmond, Virginia 23219

United States

Seattle Children's Hospital

Seattle, Washington 98105

United States

University of Wisconsin

Madison, Wisconsin 53705-9123

United States

Hospital Italiano de Buenos Aires

CABA, C1199ABB

Argentina

Hospital de Niños Dr. Ricardo Gutierrez

CABA, C1425EFD

Argentina

Equipo Ciencia

CABA, C1428BNF

Argentina

The Children's Hospital at Westmead

Westmead, New South Wales 2145

Australia

Queensland Children's Hospital

South Brisbane, Queensland 4101

Australia

Monash Children's Hospital

Clayton, Victoria 3168

Australia

The Royal Children's Hospital

Parkville, Victoria 3052

Australia

HUB CHU Brugmann

Brussels, 1020

Belgium

Cliniques Universitaires Saint-Luc

Brussels, 1200

Belgium

Universitair Ziekenhuis Gent

Ghent, 9000

Belgium

UZ Leuven

Leuven, 3000

Belgium

CHC Mont Légia

Liège, 4000

Belgium

University of Alberta Hospital (University of Alberta)

Edmonton, Alberta T6G 2B7

Canada

BC Children's Hospital

Vancouver, British Columbia V6H 3N1

Canada

The Hospital for Sick Children

Toronto, Ontario M5G 1X8

Canada

McGill University Health Centre (MUHC)

Montreal, Quebec H4A 3J1

Canada

Jim Pattison Children's Hospital

Saskatoon, Saskatchewan S7N 0W8

Canada

Hôpital Louis Pradel

Bron, 69500

France

HOP Timone

Marseille, 13005

France

HOP Enfants et Adolescents

Nantes, 44093

France

HOP Armand-Trousseau

Paris, 75012

France

Hopital Necker

Paris, 75015

France

HOP des Enfants

Toulouse, 31059

France

Universitätsklinikum Köln (AöR)

Cologne, 50937

Germany

Universitätsklinikum Hamburg, Eppendorf

Hamburg, 20246

Germany

Universitätsklinikum Heidelberg

Heidelberg, 69120

Germany

Universitätsklinikum Tübingen

Tübingen, 72076

Germany

Semmelweis University, Faculty of Medicine

Budapest, 1083

Hungary

University of Debrecen Clinical Centre

Debrecen, 4032

Hungary

University of Pecs

Pécs, 7623

Hungary

Istituto G. Gaslini

Genova, 16147

Italy

Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico

Milan, 20122

Italy

Azienda Ospedaliera Universitaria di Padova

Padova, 35128

Italy

Ospedale Pediatrico Bambino Gesù

Roma, 00165

Italy

Amsterdam University Medical Center

Amsterdam, 1105 AZ

Netherlands

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ

Netherlands

Radboud Universitair Medisch Centrum

Nijmegen, 6525 GA

Netherlands

Erasmus Medisch Centrum

Rotterdam, 3015 GD

Netherlands

UMC Utrecht

Utrecht, 3584 CX

Netherlands

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-211

Poland

University Children's Hospital in Lublin

Lublin, 20-093

Poland

Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu

Torun, 87-100

Poland

The Children's Memorial Health Institute

Warsaw, 04730

Poland

University Clinical Hospital in Wrocław

Wroclaw, 50 556

Poland

CHUC - Centro Hospitalar e Universitario de Coimbra, EPE

Coimbra, 3000-602

Portugal

ULS de São José, E.P.E. - Hospital Dona Estefânia

Lisbon, 1169-045

Portugal

ULS de Santa Maria, E.P.E

Lisbon, 1600-190

Portugal

CHUP, EPE - Centro Materno Infantil do Norte

Porto, 4050-651

Portugal

National University Hospital

Singapore, 119074

Singapore

KK Women's and Children's Hospital

Singapore, 229899

Singapore

Kyungpook National University Hospital

Daegu, 41944

South Korea

Chonnam National University Hospital

Gwangju, 61469

South Korea

Seoul National University Bundang Hospital

Seongnam, 13620

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Hospital Universitario de Cruces

Bilbao, 48903

Spain

Hospital Regional Universitario de Málaga

Málaga, 29011

Spain

Hospital Virgen del Rocío

Seville, 41013

Spain

Sahlgrenska Universitetssjukhuset, Östra

Gothenburg, 416 85

Sweden

Karolinska University Hospital

Stockholm, 141 86

Sweden

Hacettepe University

Ankara, 06230

Turkey (Türkiye)

Ankara Universitesi Tip Fakultesi

Ankara, 06620

Turkey (Türkiye)

Istanbul Capa University

Istanbul, 34093

Turkey (Türkiye)

Osmangazi University

Odunpazari, 26040

Turkey (Türkiye)

Birmingham Children's Hospital

Birmingham, B4 6NH

United Kingdom

Bristol Royal Hospital for Children

Bristol, BS2 8BJ

United Kingdom

Queen Elizabeth University Hospital

Glasgow, G51 4TF

United Kingdom

Alder Hey Children's Hospital

Liverpool, L12 2AP

United Kingdom

Great Ormond Street Hospital

London, WC1N 3JH

United Kingdom

Great North Children's Hospital

Newcastle upon Tyne, NE1 4LP

United Kingdom

Nottingham Children's Hospital

Nottingham, NG7 2UH

United Kingdom

NIHR Southampton Clinical Research Facility

Southampton, SO16 6YD

United Kingdom