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Study details
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EMPA-KIDNEY® Kids Trial

Boehringer Ingelheim
NCT IDNCT07107945ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Target enrollment

120

Study length

about 3.5 years

Ages

2–17

Locations

30 sites in AL, AZ, CA +20

About this study

This trial is testing empagliflozin in children and adolescents with chronic kidney disease (CKD). The goal is to determine if empagliflozin helps these patients and how well they tolerate the medication. Participants will take either empagliflozin or a placebo for over a year.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take Empagliflozin
  • 2.Take Placebo
PhasePhase 3
DrugEmpagliflozin
Routeoral
Primary goalChange from Day 1 to the Week 24 visit in urine albumin-creatinine (UACR) [mg/g]

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low12%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Drug classes

empagliflozin (SGLT2 inhibitor; increases glucose excretion in urine)

Drug routes

oral (Oral Tablet)

Endpoints

Primary: Change from Day 1 to the Week 24 visit in urine albumin-creatinine (UACR) [mg/g]

Secondary: 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), Change in estimated glomerular filtration rate (eGFR) (U25Crea) over time during treatment with empagliflozin, Occurrence of at least one SAE or AE of special interest (AESI) per participant 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)

Body systems

Renal