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A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)

StatusRecruiting
PhasePhase 3
Started2025-12-09
View on ClinicalTrials.gov ↗

Amendment history

2026-08-19
Study Status, Contacts/Locations v24
Trial sites reduced: 97 → 93 locations
Trial sites reduced: 102 → 97 locations
2026-08-06
Study Status, Contacts/Locations v23
Study sitesdetails revised at 6 of 102 sites
2026-07-24
Study Status, Contacts/Locations v22
Primary completion moved earlier: 2028-06-26 → 2027-04-16
Completion moved earlier: 2029-06-25 → 2028-04-14
Study sites102 entries, revised
Hackensack MeridianUniversity HealthMedical Center
2026-07-08
Study Status, Contacts/Locations v21
Study sites102 entries, revised
Wojewodzki Szpital Zespolony Im.L.Rydygiera Rydygier'sW Regional Hospital in TorunToruniu CHUC - Centro Hospitalar e UniversitárioUniversitario de Coimbra, EPE
2026-06-22
Study Status, Contacts/Locations v20
Study sites102 entries, revised
HôpitalHopital Necker UniversityUniwersyteckie ClinicalCentrum Center, GdanskKliniczne
Show 19 earlier versions
2026-06-10
Study Status, Contacts/Locations v19
Study sitesdetails revised at 2 of 102 sites
2026-05-28
Study Status, Contacts/Locations v18
Study sites102 entries, revised
Johns Hopkins UniversityHospital İstanbulIstanbul ÇapaCapa University
2026-04-27
Study Status, Contacts/Locations v17
Study sites102 entries, revised
Stanford University MedicalSchool Centerof Medicine Osp.Ospedale Pediatrico BambinBambino Gesù
2026-04-14
Study Status, Contacts/Locations v16
Study sitesdetails revised at 5 of 102 sites
2026-04-01
Study Status, Contacts/Locations v15
Study sites102 entries, revised
UniversityM ofHealth MinnesotaFairview Masonic Children's Hospital Hospital Universitari Vall D d'Hebron
2026-03-17
Study Status, Contacts/Locations v14
Study sites102 entries, revised
Virginia Commonwealth University Health Systems
2026-03-03
Study Status, Contacts/Locations v13
Study sites102 entries, revised
Riley Hospital for Children at Indiana University Health University of Michigan Health System HOPHôpital Louis Pradel
2026-02-17
Study Status, Contacts/Locations v12
Study sites100→102
2026-02-03
Study Status, Contacts/Locations, IPDSharing, References v11
Study sites100 entries, revised
CHUC - Centro HospitaisHospitalar dae UniversidadeUniversitário de Coimbra, EPE
2026-01-19
Study Status, Contacts/Locations v10
Study sites100 entries, revised
HOPHôpital Necker
2026-01-05
Study Status, Contacts/Locations v9
Study sitesdetails revised at 3 of 100 sites
2025-12-16
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v8
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-12-12→confirmed 2025-12-09
Study sites100 entries, revised
ULSCentro Hospitais da Universidade de Coimbra, E.P.E.
2025-11-17
Study Status, Contacts/Locations v7
Start date2025-11-07→2025-12-12
Study sites97→100
2025-10-27
Study Status, Contacts/Locations v6
Study sites93→97
2025-10-06
Study Status, Outcome Measures, Eligibility v5
Eligibility criteria+103 characters
[...] n/1.73 m2 with a urine-albumine-creatinine (UACR) ≥300 mg/g StableParticipants must be on a stable dose of maximally tolerated standard of care (SoC) CKD treatmenttherapy for 30 days priorbefore toscreening randomisationvisit 1 with no plans to modifychange the dose duringthroughout the trial, at the discretionduration of the investigatorplacebo-controlled duration of the trial. SoC is anticipated to include a single Renin-angiotensin-a [...] giotensin converting enzyme inhibitors (ACEi) as appropriate and tolerated. Additional use of a mineralocorticoid receptor antagonist (MRA, including finerenone [...] [...]
Secondary endpoints5 entries, revised
Annual rate of change in eGFR (U25Crea) from the Week 8 to the Week 24 visit, including treatment effect extrapolation from (adult) EMPA-KIDNEY data Change from Day 1 to the Week 24 visit in urine protein-creatinine ratio (UPCR) The observed predose plasma concentrations of empagliflozin at the Week 26 visit Occurrence of at least one SAE or AE of special interest (A [...] articipant between Day 1 and the Week 24 visit, and between the Week 24 visit and end of treatment (EoT) +7 days residual effect period (REP)
Primary endpoints2 entries, revised
Change from Day 1 to the Week 24 visit in urine albumin-creatinine (UACR) [mg/g] Change from Day 1 to the Week 24 visit in urine glucose [mmol/L]
2025-09-29
Study Status, Contacts/Locations v4
Start date2025-10-27→2025-11-07
Study sites93 entries, revised
Hospital Universitari Vall d'D Hebron
2025-09-15
Study Status, Contacts/Locations v3
Study sites92→93
2025-09-02
Study Status, Contacts/Locations v2
Study sites87→92
2025-08-18
Study Status, Contacts/Locations v1
Study sites75→87
2025-08-05
Original filing
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.
Trial Details
NCT Number NCT07107945
Lead Sponsor Boehringer Ingelheim
Conditions Chronic Kidney Disease
Enrollment 120 participants
Start Date 2025-12-09
Primary Completion 2027-04-16 (estimated)
Study Completion 2028-04-14 (estimated)
Updated on ClinicalTrials.gov 2026-09-16