Testing a medication for children with chronic kidney disease
Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease
EARLY_PHASE1 · Ann & Robert H Lurie Children's Hospital of Chicago · NCT06430684
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_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 12 Years to 25 Years |
| Sex | All |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06430684 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with heart disease, diabetes, or other significant health issues may not benefit from this study.
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 performed: While this approach is novel in the pediatric population, similar studies in adults have shown promising results with SGLT2 inhibitors.
Eligibility criteria
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 this trial is running
Chicago, Illinois
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Kidney Diseases, Pediatric Kidney Disease, Sodium Glucose Co-Transporter 2 Inhibitor, SGLT2i, Pediatric CKD, Feasibility Study, Clinical Trial