The EMPA-KIDNEY® Kids Study is testing an investigational drug to see if it could help children with chronic kidney disease (CKD). Chronic means ongoing. The investigational drug will be compared with a placebo. A placebo looks like the investigational drug but contains no active ingredients. Throughout the study, you/your child will continue to take your/their current medication for CKD.
The EMPA-KIDNEY® Kids Study could last up to 80 weeks, including:
- 4-week screening period: you/your child will have tests at the nearest study centre to see if you/they can take part.
- 24-week study treatment period (Part 1): if the study criteria match your/your child’s condition, you/they will receive either the investigational drug or placebo + your/their regular CKD medication.
- 48-week study treatment period (Part 2): you/your child will receive the investigational drug only (no placebo) + your/their regular CKD medication.
- 4-week follow-up period: you will have two more visits (one at the study centre and one via telephone), so that the study team can check on your/your child’s health and well-being.
During Part 1 of the study treatment period, you/your child will have about a 66% (2 in 3) chance of receiving the investigational drug and a 33% (1 in 3) chance of receiving placebo. During Part 2 of the study treatment period, you/your child will receive the investigational drug.
You/your child will be asked to take the investigational drug or placebo for 72 weeks + the medication you/they usually take for CKD.
Over the course of the study, you/your child will be asked to attend visits approximately every 8 weeks. Visits will take place either at the study centre or via telephone. For younger children, during months 1 and 7, health checks will happen more often. These health checks will switch between in-person and remote visits.