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A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)
Sponsor: Boehringer Ingelheim
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.
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)
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-12-09
Completion Date
2029-06-25
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Empagliflozin
Empagliflozin
Placebo
Placebo
Locations (102)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
University of California Los Angeles
Los Angeles, California, United States
Stanford University Medical Center
Palo Alto, California, United States
University of California Davis
Sacramento, California, United States
University of California San Francisco
San Francisco, California, United States
University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Novak Center for Children's Health
Louisville, Kentucky, United States
Johns Hopkins University
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
M Health Fairview Masonic Children's Hospital
Minneapolis, Minnesota, United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States
Hackensack Meridian Health
Hackensack, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Virginia Commonwealth University Health Systems
Richmond, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Hospital Italiano de Buenos Aires
CABA, Argentina
Hospital de Niños Dr. Ricardo Gutierrez
CABA, Argentina
Equipo Ciencia
CABA, Argentina
The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Queensland Children's Hospital
South Brisbane, Queensland, Australia
Monash Children's Hospital
Clayton, Victoria, Australia
The Royal Children's Hospital
Parkville, Victoria, Australia
HUB CHU Brugmann
Brussels, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
CHC Mont Légia
Liège, Belgium
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta, Canada
BC Children's Hospital
Vancouver, British Columbia, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
Jim Pattison Children's Hospital
Saskatoon, Saskatchewan, Canada
Hôpital Louis Pradel
Bron, France
HOP Timone
Marseille, France
HOP Enfants et Adolescents
Nantes, France
HOP Armand-Trousseau
Paris, France
Hôpital Necker
Paris, France
HOP des Enfants
Toulouse, France
Universitätsklinikum Köln (AöR)
Cologne, Germany
Universitätsklinikum Hamburg, Eppendorf
Hamburg, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Semmelweis University, Faculty of Medicine
Budapest, Hungary
University of Debrecen Clinical Centre
Debrecen, Hungary
University of Pecs
Pécs, Hungary
Istituto G. Gaslini
Genova, Italy
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
Milan, Italy
Azienda Ospedaliera Universitaria di Padova
Padova, Italy
Osp. Pediatrico Bambin Gesù
Roma, Italy
Amsterdam University Medical Center
Amsterdam, Netherlands
Universitair Medisch Centrum Groningen
Groningen, Netherlands
Radboud Universitair Medisch Centrum
Nijmegen, Netherlands
Erasmus Medisch Centrum
Rotterdam, Netherlands
UMC Utrecht
Utrecht, Netherlands
University Clinical Center, Gdansk
Gdansk, Poland
University Children's Hospital in Lublin
Lublin, Poland
L. Rydygier's Regional Hospital in Torun
Torun, Poland
The Children's Memorial Health Institute
Warsaw, Poland
University Clinical Hospital in Wrocław
Wroclaw, Poland
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, Portugal
ULS de São José, E.P.E. - Hospital Dona Estefânia
Lisbon, Portugal
ULS de Santa Maria, E.P.E
Lisbon, Portugal
CHUP, EPE - Centro Materno Infantil do Norte
Porto, Portugal
National University Hospital
Singapore, Singapore
KK Women's and Children's Hospital
Singapore, Singapore
Kyungpook National University Hospital
Daegu, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Seoul National University Hospital
Seoul, South Korea
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario de Cruces
Bilbao, Spain
Hospital Regional Universitario de Málaga
Málaga, Spain
Hospital Virgen del Rocío
Seville, Spain
Sahlgrenska Universitetssjukhuset, Östra
Gothenburg, Sweden
Karolinska University Hospital
Stockholm, Sweden
Hacettepe University
Ankara, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi
Ankara, Turkey (Türkiye)
İstanbul Çapa University
Istanbul, Turkey (Türkiye)
Osmangazi University
Odunpazari, Turkey (Türkiye)
Birmingham Children's Hospital
Birmingham, United Kingdom
Bristol Royal Hospital for Children
Bristol, United Kingdom
Queen Elizabeth University Hospital
Glasgow, United Kingdom
Alder Hey Children's Hospital
Liverpool, United Kingdom
Great Ormond Street Hospital
London, United Kingdom
Great North Children's Hospital
Newcastle upon Tyne, United Kingdom
Nottingham Children's Hospital
Nottingham, United Kingdom
NIHR Southampton Clinical Research Facility
Southampton, United Kingdom