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
What is the goal of the study?
The prevalence of children with chronic kidney disease (CKD) is increasing over time. Patients with CKD develop numerous co-morbidities that impact both quality and duration of life. In adult patients with CKD, sodium glucose cotransporter (SGLT)-2 inhibitors, and specifically empagliflozin, have been unequivocally shown to safely prolong the decline in kidney function, in both short- and long-term studies. There is no marketed drug available for this indication in children. The aim of this trial is to provide important clinical and pharmacologic information to guide the safe use of empagliflozin in pediatric patients with CKD. The main objective of this trial is to assess the pharmacokinetics (PK), safety, and efficacy of empagliflozin (p.o.) in addition to standard of care in paediatric patients aged 2 to 17 years with CKD at risk of progression. The primary objectives are to measure the pre-dose plasma concentrations of empagliflozin after 26 weeks and assess safety of empagliflozin during the randomized controlled phase and the open-label phase. The primary treatment comparison will be by the PK set for the observed pre-dose plasma concentrations, and by treated set for safety evaluations.
Who can participate in the study?
Please contact the study team listed below to learn more.