A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)
This study, called EMPA-KIDNEY® Kids, is for children and teenagers aged 2 to 17 who have ongoing kidney disease. The main goal is to find out if a medicine called empagliflozin can help improve their kidney health. We also want to understand how their bodies react to the medicine and if they experience any side effects. Participants are split into two groups by chance. One group receives empagliflozin, and the other receives a placebo, which looks like the medicine but contains no active drug. Twice as many participants will get the actual medicine. Everyone takes a tablet once a day for 6 months. After this, all participants will take empagliflozin daily for another year. The study lasts about 18 months, with regular check-ups and phone calls.
At a glance
What is this study about?
This study is called EMPA-KIDNEY® Kids, and it's designed for children and teenagers aged 2 to 17 who have a condition known as chronic kidney disease (CKD). Chronic kidney disease means the kidneys aren't working as well as they should and this is a long-term problem. We want to carefully investigate a medicine called empagliflozin to see if it can help improve kidney health in young people.
We also want to understand how well children and teenagers tolerate empagliflozin. This means checking for any side effects and seeing how the medicine affects their bodies. Your child will be in the study for about a year and a half, visiting the clinic regularly for check-ups.
By taking part, your child could help us learn more about treating chronic kidney disease in young people. This information could hopefully lead to better ways to help other children with similar kidney problems in the future.
Key takeaways
- This study is for children and teenagers (2-17 years old) with chronic kidney disease.
- It aims to see if empagliflozin medicine can help improve kidney health and is safe.
- Participants take a tablet daily for 18 months, either empagliflozin or a placebo initially.
- There are regular clinic visits and phone calls to monitor health.
- The study could provide important information for treating kidney disease in young people.
Who may be eligible?
This study is looking for children and teenagers who are currently between 2 and 17 years old. They need to have chronic kidney disease, and their kidney function will be checked to make sure it falls within a certain range. This might be a good fit if your child is already taking stable medication for their kidney condition, such as certain blood pressure medicines, as these usually need to stay the same throughout the study.
There are also some reasons why a child might not be able to join. For example, children with type 1 or type 2 diabetes, or those who have had a condition called ketoacidosis recently, cannot take part. Also, if your child is currently on dialysis, has had a kidney transplant, or is planning to have a transplant during the study, they would not be eligible.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Is your child aged between 2 and 17 years old?
- Does your child have chronic kidney disease?
- Is your child's current kidney medication dose stable (hasn't changed recently)?
- Does your child NOT have type 1 or type 2 diabetes?
- Is your child NOT currently on dialysis or waiting for a kidney transplant?
What does participation involve?
If your child joins the study, they will take either the study medicine (empagliflozin) or a dummy pill (placebo) once a day as a tablet for 6 months. After these first 6 months, everyone in the study will take empagliflozin once a day for another year. There's a 2 in 3 chance your child will get the active medicine from the start.
The study will last for about a year and a half in total. During this time, your child will need to visit the study clinic about 15 times for check-ups. There will also be at least 5 phone or video calls with the study team. At these visits, doctors will take blood and urine samples, and carefully monitor your child's overall health and any effects of the medicine.
Potential risks and benefits
Locations (102)
- University of Alabama at BirminghamVerified postcodeBirmingham, United States· Not yet recruiting
- Phoenix Children's HospitalVerified postcodePhoenix, United States· Not yet recruiting
- University of California Los AngelesVerified postcodeLos Angeles, United States· Not yet recruiting
- Stanford University School of MedicineVerified postcodePalo Alto, United States· Not yet recruiting
- University of California DavisVerified postcodeSacramento, United States· Not yet recruiting
- University of California San FranciscoVerified postcodeSan Francisco, United States· Not yet recruiting
- University of MiamiVerified postcodeMiami, United States· Not yet recruiting
- Emory UniversityVerified postcodeAtlanta, United States· Not yet recruiting
- Ann & Robert H. Lurie Children's Hospital of ChicagoVerified postcodeChicago, United States· Not yet recruiting
- Indiana UniversityVerified postcodeIndianapolis, United States· Recruiting
- Novak Center for Children's HealthVerified postcodeLouisville, United States· Not yet recruiting
- Johns Hopkins HospitalVerified postcodeBaltimore, United States· Not yet recruiting
Common questions
What is chronic kidney disease (CKD)?
Chronic kidney disease means your child's kidneys are not working as well as they should be, and this is a long-term problem.
What is empagliflozin?
Empagliflozin is a medicine being studied to see if it can help people with kidney disease.
What is a placebo?
A placebo is a dummy pill that looks like the real medicine but does not contain any active drug. It helps us see if the medicine really works better than no medicine at all.
How long does the study last?
The study will last for about a year and a half (18 months) in total.
Can we stop participating at any time?
Yes, you can withdraw your child from the study at any point, and it won't affect their regular medical care.
How to find out more
Boehringer Ingelheim
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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