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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07107945
Registration number
NCT07107945
Ethics application status
Date submitted
5/08/2025
Date registered
6/08/2025
Date last updated
3/09/2025
Titles & IDs
Public title
A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)
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Scientific title
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)
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Secondary ID [1]
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2024-512577-27-00
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Secondary ID [2]
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1245-0256
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease
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Condition category
Condition code
Renal and Urogenital
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Empagliflozin
Treatment: Drugs - Placebo
Experimental: Empagliflozin treatment arm -
Placebo comparator: Placebo arm -
Treatment: Drugs: Empagliflozin
Empagliflozin
Treatment: Drugs: Placebo
Placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from Day 1 to Week 24 in urine albumin-creatinine (UACR) [mg/g]
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Assessment method [1]
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Timepoint [1]
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Up to week 24
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Primary outcome [2]
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Change from Day 1 to Week 24 in urine glucose [mmol/L]
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Assessment method [2]
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Timepoint [2]
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Up to week 24
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Secondary outcome [1]
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Change in estimated glomerular filtration rate (eGFR) (U25Crea) over time during treatment with empagliflozin
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Assessment method [1]
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U25Crea = estimates the glomerular filtration rate based on creatinine in patients aged up to 25 years
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Timepoint [1]
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Up to week 73
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Secondary outcome [2]
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Annual rate of change in eGFR (U25Crea) from Week 8 to Week 24, including treatment effect extrapolation from (adult) EMPA-KIDNEY data
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Assessment method [2]
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Timepoint [2]
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Up to week 24
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Secondary outcome [3]
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Change from Day 1 to Week 24 in urine protein-creatinine ratio (UPCR)
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Assessment method [3]
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Timepoint [3]
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Up to week 24
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Secondary outcome [4]
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The observed predose plasma concentrations of empagliflozin at Week 26
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Assessment method [4]
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Timepoint [4]
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Up to week 26
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Secondary outcome [5]
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Occurrence of at least one SAE or AE of special interest (AESI) per participant between Day 1 and the Week 24 visit, and between Week 24 and end of treatment (EoT) +7 days residual effect period (REP)
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Assessment method [5]
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SAE= serious adverse event AE= adverse event
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Timepoint [5]
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Up to week 73
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Eligibility
Key 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
* Stable standard of care (SoC) CKD treatment for 30 days prior to randomisation with no plans to modify the dose during the trial, at the discretion of the investigator. 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. Additional use of a mineralocorticoid receptor antagonist (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
* Participants on daily immunosuppressive medication to treat an underlying immunologic cause of CKD must be on a stable dose for 30 days before screening Visit 1 and until randomisation Visit 2. Participants who are taking rituximab or cyclophosphamide should have last taken a dose =120 days before screening Visit 1.
* Further inclusion criteria apply.
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Minimum age
2
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Maximum age
17
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Confirmed type 1 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
27/10/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
25/06/2029
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Actual
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Sample size
Target
120
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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The Children's Hospital at Westmead - Westmead
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Queensland Children's Hospital - South Brisbane
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Monash Children's Hospital - Clayton
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The Royal Children's Hospital - Parkville
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2145 - Westmead
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4101 - South Brisbane
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3168 - Clayton
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3052 - Parkville
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Boehringer Ingelheim
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT07107945
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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Boehringer Ingelheim
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Phone
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1-800-243-0127
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
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Available to whom?
For study documents - upon signing of a 'Document Sharing Agreement'.
For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07107945
Download to PDF