A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids)
Recruiting · 40 sites across 26 states
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is this study?
This study is open to children aged 2 to 17 with chronic kidney disease (CKD). The purpose of this study is to find out if a medicine called empagliflozin helps children and adolescents with CKD.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
This study is open to children aged 2 to 17 with chronic kidney disease (CKD). The purpose of this study is to find out if a medicine called empagliflozin helps children and adolescents with CKD. Other goals of the study are to find out how empagliflozin is tolerated and handled by the body in children and adolescents with CKD. Participants are put into 2 groups randomly, which means by chance. One group takes empagliflozin and the other group takes placebo. Placebo looks like empagliflozin but does not contain any medicine. Participants are twice as likely to be in the empagliflozin group. Participants take empagliflozin or placebo as tablets once a day for 6 months. After 6 months, participants in both groups take empagliflozin as tablets once a day for 1 year. Participants are in the study for a little over a year and a half. During this time, they visit the study site about 15 times and get at least 5 phone or video calls from the site staff. At the visits, the doctors take blood and urine samples from the participants. The doctors also regularly check participants' health and take note of any unwanted effects.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Children age 2 to 17 at the start of the study (screening Visit 1).
- •Have chronic kidney disease (CKD) based on lab results (eGFR and urine protein).
- •Have been on a stable standard treatment for 30 days before screening (and no plans to change it during the placebo period).
- •If the CKD is from an immune cause and requires daily immune-suppressing medicine, the dose must be stable.
- •Parent/legal guardian consent and the child’s agreement (assent) are collected as appropriate for age and understanding.
🚫 You may not be able to join if…
- •Have type 1 or type 2 diabetes.
- •Had ketoacidosis in the 8 weeks before Visit 1 up to the time of randomization.
- •Are on chronic dialysis, have a kidney transplant that is working, or plan a transplant during the trial.
- •Have uncontrolled metabolic bone disease (if the investigator decides it is uncontrolled).
- •Have very low BMI for their age based on CDC growth charts (BMI at or below the 10th percentile for ages ≥4; BMI at or below the 25th percentile for ages <4).
- •Have gastrointestinal problems that could interfere with how the trial drug is absorbed (investigator decides).
- •Have an active urine infection (UTI) or were treated for one within 14 days before screening.
- •Have severe uncontrolled high blood pressure (investigator decides).
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 2–17
- ✓Have Kidney disease
- !Some conditions may not be a fit: Obesity / overweight, Type 2 diabetes, High blood pressure
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
What you need to know before you apply
What is this study testing?+
This study is open to children aged 2 to 17 with chronic kidney disease (CKD). The purpose of this study is to find out if a medicine called empagliflozin helps children and adolescents with CKD.
Is it safe? Who makes sure of that?+
This is a late-stage study (Phase 3), testing how well the treatment works in more people. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Source: ClinicalTrials.gov · NCT07107945 · Locations: Alabama · Arizona · California · Florida · Georgia · Illinois · Indiana · Kentucky · Maryland · Massachusetts · Michigan · Minnesota · Missouri · New Jersey · New Mexico · Ohio · Pennsylvania · Tennessee · Texas · Utah · Virginia · Washington · Wisconsin · New South Wales · Queensland · Victoria