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