A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)
Recruiting · NCT07107945 · Interventional (participants receive a specific treatment) · Lead sponsor: Boehringer Ingelheim
View the official record on ClinicalTrials.gov →Interventions studied
EmpagliflozinPlacebo
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.
Who can take part
Age range
2 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 20 US states.
- University of Alabama at Birmingham - Birmingham, Alabama, United States
- Stanford University School of Medicine - 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 Hospital - Baltimore, Maryland, 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 University Medical Center - 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
- Children's Hospital of Philadelphia - Philadelphia, Pennsylvania, United States
- Vanderbilt University Medical Center - Nashville, Tennessee, 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
- Amsterdam University Medical Center - Amsterdam, Netherlands
- Hacettepe University - Ankara, Turkey (Türkiye)
- Ankara Universitesi Tip Fakultesi - Ankara, Turkey (Türkiye)
- Hospital Universitari Vall d'Hebron - Barcelona, Spain
- Hospital Universitario de Cruces - Bilbao, Spain
- Birmingham Children's Hospital - Birmingham, United Kingdom
- Bristol Royal Hospital for Children - Bristol, United Kingdom
- Hopital Louis Pradel - Bron, France
- HUB CHU Brugmann - Brussels, Belgium
- Cliniques Universitaires Saint-Luc - Brussels, Belgium
- Semmelweis University, Faculty of Medicine - Budapest, Hungary
- Hospital Italiano de Buenos Aires - CABA, Argentina
- Hospital de Niños Dr. Ricardo Gutierrez - CABA, Argentina
- Equipo Ciencia - CABA, Argentina
- CHUC - Centro Hospitalar e Universitario de Coimbra, EPE - Coimbra, Portugal
- Universitätsklinikum Köln (AöR) - Cologne, Germany
- Kyungpook National University Hospital - Daegu, South Korea
- University of Debrecen Clinical Centre - Debrecen, Hungary
- Uniwersyteckie Centrum Kliniczne - Gdansk, Poland
- Istituto G. Gaslini - Genova, Italy
- Universitair Ziekenhuis Gent - Ghent, Belgium
- Queen Elizabeth University Hospital - Glasgow, United Kingdom
- Sahlgrenska Universitetssjukhuset, Ostra - Gothenburg, Sweden
- Universitair Medisch Centrum Groningen - Groningen, Netherlands
- Chonnam National University Hospital - Gwangju, South Korea
- Universitätsklinikum Hamburg, Eppendorf - Hamburg, Germany
- Universitätsklinikum Heidelberg - Heidelberg, Germany
- Istanbul Capa University - Istanbul, Turkey (Türkiye)
- UZ Leuven - Leuven, Belgium
- ULS de Sao Jose, E.P.E. - Hospital Dona Estefania - Lisbon, Portugal
- Alder Hey Children's Hospital - Liverpool, United Kingdom
- CHC Mont Legia - Liège, Belgium
- Great Ormond Street Hospital - London, United Kingdom
- HOP Timone - Marseille, France
- Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico - Milan, Italy
Showing 60 of 93 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →