Chronic kidney disease in paediatric patients
Conditions
Brief summary
Change from Day 1 to Week 24 in UACR [mg/g], Change from Day 1 to Week 24 in urine glucose [mmol/L]
Detailed description
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 Week 24 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 Week 24 and end of treatment (EoT) +7 days residual effect period (REP)
Interventions
DRUGempagliflozin
DRUGJardiance 10 mg film-coated tablets
DRUGPlacebo matching empagliflozin
Sponsors
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Day 1 to Week 24 in UACR [mg/g], Change from Day 1 to Week 24 in urine glucose [mmol/L] | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Week 24 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 Week 24 and end of treatment (EoT) +7 days residual effect period (REP) | — |
Countries
Belgium, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Spain, Sweden
Outcome results
None listed