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Looking for participantsPhase3

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

NCT ID: NCT07107945

View on ClinicalTrials.gov ↗

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.

Chronic Kidney Disease

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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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

eGFR

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
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 Is This Study? (8 UK sites)

Birmingham Children's Hospital

Birmingham B4 6NH, United Kingdom

Recruiting
Site contact (verified)

Bristol Royal Hospital for Children

Bristol BS2 8BJ, United Kingdom

Recruiting
Site contact (verified)

Queen Elizabeth University Hospital

Glasgow G51 4TF, United Kingdom

Recruiting
Site contact (verified)

Alder Hey Children's Hospital

Liverpool L12 2AP, United Kingdom

Recruiting
Site contact (verified)

Great Ormond Street Hospital

London WC1N 3JH, United Kingdom

Recruiting
Site contact (verified)

Great North Children's Hospital

Newcastle upon Tyne NE1 4LP, United Kingdom

ACTIVE_NOT_RECRUITING

Nottingham Children's Hospital

Nottingham NG7 2UH, United Kingdom

Recruiting
Site contact (verified)

NIHR Southampton Clinical Research Facility

Southampton SO16 6YD, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Boehringer Ingelheim

Sponsor contact

CONTACT

1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09