At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Empagliflozin (drug), Placebo (drug)
- How long the study runs
- Study runs about 28 months (dates as stated)
- About the drug or intervention
- Empagliflozin — drug: Empagliflozin · Placebo — drug: Placebo
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 2 Years to 17 Years
- Who
- All
- Number of participants
- 120
- Started
- 2025-12-09
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for chronic kidney disease
- • Phase3 - 120 participants
- • This study is open to children aged 2 to 17 with chronic kidney disease (CKD)
Who can take part?
- • Ages 2 Years to 17 Years
- • Diagnosed with chronic kidney disease
Where?
- • Birmingham - Birmingham Children's Hospital
- • Bristol - Bristol Royal Hospital for Children
- • Glasgow - Queen Elizabeth University Hospital
- • Liverpool - Alder Hey Children's Hospital
- • +4 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 2 Years - 17 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Age 2 to 17 years at screening Visit 1.
- ✓Further inclusion criteria apply.
Who cannot take part
- ✗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).
- ✗Gastrointestinal disorders that might interfere with trial drug absorption according to investigator assessment.
See the full criteria
Where Is This Study? (8 UK sites)
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
How to Get in Touch
Boehringer Ingelheim
Sponsor contactCONTACT
