Actively Recruiting
A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)
Led by Boehringer Ingelheim · Updated on 2026-04-28
120
Participants Needed
102
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent by parent or guardian and assent by participant as appropriate
- Age 2 to 17 years at screening
- Chronic kidney disease with estimated glomerular filtration rate (eGFR) 20 to less than 90 mL/min/1.73 m2 and urine albumin-creatinine ratio (UACR) of 300 mg/g or more
- Stable dose of maximally tolerated standard of care therapy including a renin-angiotensin-aldosterone system (RAAS) inhibitor for at least 30 days before screening with no planned dose changes during placebo-controlled period
- Stable dose of immunosuppressive therapy if used for immunological CKD cause prior to screening and throughout placebo-controlled period
- Further inclusion criteria apply
You will not qualify if you...
- Confirmed diagnosis of type 1 or type 2 diabetes mellitus
- History of ketoacidosis within 8 weeks before screening
- Currently on chronic dialysis, has a functioning kidney transplant, or scheduled for kidney transplantation during the trial
- Diagnosis of uncontrolled metabolic bone disease
- Body mass index (BMI) below the 10th percentile for children 4 years or older and below the 25th percentile for children under 4 years, based on CDC growth charts
- Gastrointestinal disorders that may affect drug absorption
- Acute or active urinary tract infection or treated for infection within 14 days before screening
- Severe, uncontrolled hypertension
- Further exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 102 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Not Yet Recruiting
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Not Yet Recruiting
3
University of California Los Angeles
Los Angeles, California, United States, 90095
Not Yet Recruiting
4
Stanford University School of Medicine
Palo Alto, California, United States, 94301
Not Yet Recruiting
5
University of California Davis
Sacramento, California, United States, 95817
Not Yet Recruiting
6
University of California San Francisco
San Francisco, California, United States, 94158
Not Yet Recruiting
7
University of Miami
Miami, Florida, United States, 33136
Not Yet Recruiting
8
Emory University
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
9
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Not Yet Recruiting
10
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
11
Novak Center for Children's Health
Louisville, Kentucky, United States, 40202
Not Yet Recruiting
12
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Not Yet Recruiting
13
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
14
University of Michigan
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
15
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Not Yet Recruiting
16
M Health Fairview Masonic Children's Hospital
Minneapolis, Minnesota, United States, 55454
Not Yet Recruiting
17
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Not Yet Recruiting
18
Hackensack Meridian Health
Hackensack, New Jersey, United States, 07601
Not Yet Recruiting
19
Jersey Shore University Medical Center
Neptune City, New Jersey, United States, 07753
Not Yet Recruiting
20
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Not Yet Recruiting
21
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Not Yet Recruiting
22
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
23
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Not Yet Recruiting
24
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
25
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Not Yet Recruiting
26
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235
Not Yet Recruiting
27
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Not Yet Recruiting
28
Virginia Commonwealth University Health Systems
Richmond, Virginia, United States, 23219
Not Yet Recruiting
29
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Not Yet Recruiting
30
University of Wisconsin
Madison, Wisconsin, United States, 53705-9123
Not Yet Recruiting
31
Hospital Italiano de Buenos Aires
CABA, Argentina, C1199ABB
Not Yet Recruiting
32
Hospital de Niños Dr. Ricardo Gutierrez
CABA, Argentina, C1425EFD
Not Yet Recruiting
33
Equipo Ciencia
CABA, Argentina, C1428BNF
Actively Recruiting
34
The Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
Not Yet Recruiting
35
Queensland Children's Hospital
South Brisbane, Queensland, Australia, 4101
Not Yet Recruiting
36
Monash Children's Hospital
Clayton, Victoria, Australia, 3168
Not Yet Recruiting
37
The Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Not Yet Recruiting
38
HUB CHU Brugmann
Brussels, Belgium, 1020
Not Yet Recruiting
39
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
40
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Not Yet Recruiting
41
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
42
CHC Mont Légia
Liège, Belgium, 4000
Not Yet Recruiting
43
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta, Canada, T6G 2B7
Not Yet Recruiting
44
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
Not Yet Recruiting
45
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Not Yet Recruiting
46
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada, H4A 3J1
Not Yet Recruiting
47
Jim Pattison Children's Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Not Yet Recruiting
48
Hôpital Louis Pradel
Bron, France, 69500
Actively Recruiting
49
HOP Timone
Marseille, France, 13005
Not Yet Recruiting
50
HOP Enfants et Adolescents
Nantes, France, 44093
Not Yet Recruiting
51
HOP Armand-Trousseau
Paris, France, 75012
Actively Recruiting
52
Hôpital Necker
Paris, France, 75015
Not Yet Recruiting
53
HOP des Enfants
Toulouse, France, 31059
Not Yet Recruiting
54
Universitätsklinikum Köln (AöR)
Cologne, Germany, 50937
Not Yet Recruiting
55
Universitätsklinikum Hamburg, Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
56
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Not Yet Recruiting
57
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Actively Recruiting
58
Semmelweis University, Faculty of Medicine
Budapest, Hungary, 1083
Not Yet Recruiting
59
University of Debrecen Clinical Centre
Debrecen, Hungary, 4032
Not Yet Recruiting
60
University of Pecs
Pécs, Hungary, 7623
Not Yet Recruiting
61
Istituto G. Gaslini
Genova, Italy, 16147
Actively Recruiting
62
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
Milan, Italy, 20122
Not Yet Recruiting
63
Azienda Ospedaliera Universitaria di Padova
Padova, Italy, 35128
Not Yet Recruiting
64
Ospedale Pediatrico Bambino Gesù
Roma, Italy, 00165
Actively Recruiting
65
Amsterdam University Medical Center
Amsterdam, Netherlands, 1105 AZ
Actively Recruiting
66
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713 GZ
Actively Recruiting
67
Radboud Universitair Medisch Centrum
Nijmegen, Netherlands, 6525 GA
Not Yet Recruiting
68
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 GD
Not Yet Recruiting
69
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Not Yet Recruiting
70
University Clinical Center, Gdansk
Gdansk, Poland, 80-211
Not Yet Recruiting
71
University Children's Hospital in Lublin
Lublin, Poland, 20-093
Not Yet Recruiting
72
L. Rydygier's Regional Hospital in Torun
Torun, Poland, 87-100
Not Yet Recruiting
73
The Children's Memorial Health Institute
Warsaw, Poland, 04730
Not Yet Recruiting
74
University Clinical Hospital in Wrocław
Wroclaw, Poland, 50 556
Not Yet Recruiting
75
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, Portugal, 3000-602
Actively Recruiting
76
ULS de São José, E.P.E. - Hospital Dona Estefânia
Lisbon, Portugal, 1169-045
Not Yet Recruiting
77
ULS de Santa Maria, E.P.E
Lisbon, Portugal, 1600-190
Not Yet Recruiting
78
CHUP, EPE - Centro Materno Infantil do Norte
Porto, Portugal, 4050-651
Actively Recruiting
79
National University Hospital
Singapore, Singapore, 119074
Not Yet Recruiting
80
KK Women's and Children's Hospital
Singapore, Singapore, 229899
Actively Recruiting
81
Kyungpook National University Hospital
Daegu, South Korea, 41944
Not Yet Recruiting
82
Chonnam National University Hospital
Gwangju, South Korea, 61469
Actively Recruiting
83
Seoul National University Bundang Hospital
Seongnam, South Korea, 13620
Actively Recruiting
84
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
85
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
86
Hospital Universitario de Cruces
Bilbao, Spain, 48903
Actively Recruiting
87
Hospital Regional Universitario de Málaga
Málaga, Spain, 29011
Not Yet Recruiting
88
Hospital Virgen del Rocío
Seville, Spain, 41013
Not Yet Recruiting
89
Sahlgrenska Universitetssjukhuset, Östra
Gothenburg, Sweden, 416 85
Not Yet Recruiting
90
Karolinska University Hospital
Stockholm, Sweden, 141 86
Not Yet Recruiting
91
Hacettepe University
Ankara, Turkey (Türkiye), 06230
Not Yet Recruiting
92
Ankara Universitesi Tip Fakultesi
Ankara, Turkey (Türkiye), 06620
Not Yet Recruiting
93
İstanbul Çapa University
Istanbul, Turkey (Türkiye), 34093
Not Yet Recruiting
94
Osmangazi University
Odunpazari, Turkey (Türkiye), 26040
Not Yet Recruiting
95
Birmingham Children's Hospital
Birmingham, United Kingdom, B4 6NH
Not Yet Recruiting
96
Bristol Royal Hospital for Children
Bristol, United Kingdom, BS2 8BJ
Actively Recruiting
97
Queen Elizabeth University Hospital
Glasgow, United Kingdom, G51 4TF
Actively Recruiting
98
Alder Hey Children's Hospital
Liverpool, United Kingdom, L12 2AP
Actively Recruiting
99
Great Ormond Street Hospital
London, United Kingdom, WC1N 3JH
Actively Recruiting
100
Great North Children's Hospital
Newcastle upon Tyne, United Kingdom, NE1 4LP
Not Yet Recruiting
101
Nottingham Children's Hospital
Nottingham, United Kingdom, NG7 2UH
Not Yet Recruiting
102
NIHR Southampton Clinical Research Facility
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
B
Boehringer Ingelheim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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