Evaluating Safety and Effectiveness of Empagliflozin in Children and Teens with Chronic Kidney Disease

What this Trial Is About

Researchers are evaluating how the medicine empagliflozin affects children and adolescents aged 2 to 17 years with chronic kidney disease CKD. The study aims to find out if empagliflozin helps this population and how well it is tolerated and processed by their bodies. This is a phase 3 clinical trial with participants randomly assigned to different treatment groups. Participants are randomly placed into two groups one group takes empagliflozin and the other takes a placebo, which looks like the medicine but contains no active drug. Participants are twice as likely to receive empagliflozin. They take their assigned tablets once daily for 6 months. After this, all participants take empagliflozin once daily for an additional year. During the study, which lasts a little over 18 months, participants visit the study site about 15 times and have at least 5 phone or video calls with the study staff. At these visits, doctors collect blood and urine samples and monitor participants health, noting any side effects. The primary outcomes measured include changes in urine albumin-creatinine ratio and urine glucose levels over 24 weeks.

A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)