EMPA-KIDNEY® Kids Trial
Phase 3
120
about 3.5 years
2–17
30 sites in AL, AZ, CA +20
What this study is about
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.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Empagliflozin
- 2.Take Placebo
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
empagliflozin (SGLT2 inhibitor; increases glucose excretion in urine)
oral (Oral Tablet)
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)
Renal