Testing Empagliflozin against a placebo for chronic kidney disease
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)
A Randomised, Double-blind, Placebo-controlled Trial With an Open-label Extension to Assess the Pharmacokinetics, Safety, and Efficacy of Empagliflozin Tablets in Paediatric Patients With Chronic Kidney Disease (EMPA-KIDNEY® Kids)
- Phase 3
- 2 groups
- Sites in Edmonton, Vancouver and 3 more cities
- Recruiting
Interventions
- Medication
Empagliflozin
Empagliflozin
- Medication
Placebo
Placebo
Canadian Sites (5)
5 of 5 recruiting
- Recruiting
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta
- Recruiting
BC Children's Hospital
Vancouver, British Columbia
- Recruiting
The Hospital for Sick Children
Toronto, Ontario
- Recruiting
McGill University Health Centre (MUHC)
Montreal, Quebec
- Recruiting
Jim Pattison Children's Hospital
Saskatoon, Saskatchewan
Eligibility Criteria
See who this study is looking for15 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age 2 to 17 years at screening VisitScreeningThe checks done before joining, to see whether a study fits.Read more → 1.
- +Signed and dated written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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).
- +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 careStandard of careThe treatment normally given for a condition outside a study.Read more → (SoC) therapy for 30 days before screening visit 1 with no plans to change the dose throughout the duration of the placebo-controlledPlacebo-controlledThe study compares the treatment against a dummy treatment.Read more → 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 placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →-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 criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → apply.
Exclusion
- −Confirmed type 1 or type 2 diabetes mellitus.
- −History of ketoacidosis within 8 weeks prior to Visit 1 and up to randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- −Chronic dialysis or functioning kidney transplant or scheduled for transplantation throughout the duration of the trial.
- −Diagnosis of uncontrolled metabolic bone disease (at the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'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 ControlControl groupThe group a new treatment is measured against.Read more → and Prevention (CDC) growth chart at screening VisitScreeningThe checks done before joining, to see whether a study fits.Read more → 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 criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → apply.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Empagliflozin.
Registry label: A: Empagliflozin treatment arm
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: B: Placebo arm
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 2 years to 17 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 120 people.
The study is currently expected to finish around April 2028.
The main measurement is taken over: Up to week 24.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change from Day 1 to the Week 24 visit in urine albumin-creatinine (UACR) [mg/g] — measured over Up to week 24.
Change from Day 1 to the Week 24 visit in urine glucose [mmol/L] — measured over Up to week 24.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07107945 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About EmpagliflozinDrug
Empagliflozin
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Placebo
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 2 years to 17 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 2 years to 17 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to week 24.
The study as a whole is currently expected to finish around 2028-04-14.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 120 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 9 locations, including: Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Saskatoon, Saskatchewan, Canada; Ann Arbor, Michigan, United States, and 3 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
Other Sites (4)
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
Seattle Children's Hospital
Seattle, Washington, United States
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.