Testing a medication for children with chronic kidney disease
Official title: Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease
Run by Ann & Robert H Lurie Children's Hospital of Chicago · NCT06430684 · Data updated 2026-11-12
This study is testing if a new kidney medication can help children with chronic kidney disease feel better and improve their health over three months.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 12 Years to 25 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | August 23, 2024 |
| Main results expected | September 1, 2026 |
| Study ends | November 1, 2026 |
| Registry record updated | August 19, 2026 |
| Trial ID | NCT06430684 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are youth aged with stage 3-4 chronic kidney disease and an estimated GFR of 20-60 mL/min/1.73m².
✕Probably not a fit
Patients with heart disease, diabetes, or other significant health issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial aims to determine the feasibility of conducting a clinical trial with sodium-glucose co-transporter 2 inhibitors (SGLT2i) in pediatric patients suffering from chronic kidney disease (CKD). The study will enroll 40 youth with CKD to assess whether treatment with empagliflozin over three months can lead to improvements in blood, urine, and heart function tests. Participants will be randomly assigned to receive either empagliflozin or continue their usual care, with regular check-ins and clinic visits for monitoring. The primary focus is on evaluating both the feasibility of enrollment and the potential health benefits of the medication.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that improves kidney and heart health in children with chronic kidney disease.
How similar studies have gone: While this approach is novel in the pediatric population, similar studies in adults have shown promising results with SGLT2 inhibitors.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL/min/1.73m2 Exclusion Criteria: * Heart Disease * Diabetes * Pregnancy * Recipient of solid organ transplant * history of chemotherapy or stem cell transplant * moderate to severe persistent asthma * liver disease * class 2 or greater obesity * inability to follow study procedures due to cognitive impairment * obstructive uropathy or requirement for intermittent urinary catheterization * systolic blood pressure \<100mgHg * orthostatic hypotension * current use of an SGLT2i * anticipated need for titration of anti-hypertensives within 3 months * active use of any immunosuppressive medications * lack of clearance by primary nephrologist for participation
Where it's running
-
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States Recruiting
Study contacts
- Study coordinator: Alexander J Kula, MD, MHS
- Email: alexkula@luriechildrens.org
- Phone: 312-227-6160
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Clinical decision support to help consider SGLT2 inhibitors after AKI in type 2 diabetes
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Calciphylaxis in people with chronic kidney disease: causes, risks, and early signs
This project will compare adults with chronic kidney disease who develop calciphylaxis to matched CKD patients who do not, collecting clinical data and biological samples to try to find risk factors and early signs.
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Oral Semaglutide for CKD and MAFLD in adults with diabetes
This study tests whether adding oral semaglutide to standard care can slow kidney and liver disease progression in adults with CKD and MAFLD who have type 2 diabetes.
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Eye-brain-kidney connections in chronic kidney disease
This study will see if changes in brain network connectivity and retinal blood vessels are linked to cognitive decline and kidney function in adults with chronic kidney disease.
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Screening for chronic kidney disease
We will see how common chronic kidney disease is among adults followed at a tertiary care center and how many cases were previously undiagnosed.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.