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)

Condition studied

Chronic kidney disease in paediatric patients

Investigational medicinal product(s)

Eligibility

Primary endpoint

Change from Day 1 to the Week 24 visit in UACR [mg/g], Change from Day 1 to the Week 24 visit in urine glucose [mmol/L]

Endpoint detail

Change in eGFR (U25Crea) over time during treatment with empagliflozin, Annual rate of change in eGFR (U25Crea) from Week 8 to Week 24, including treatment effect extrapolation from (adult) EMPA-KIDNEY data, Change from Day 1 to the Week 24 visit in UPCR, The observed predose plasma concentrations of empagliflozin at Week 26, 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)