Actively Recruiting
Feasibility Trial of Sodium-Glucose Co-Transporter 2 Inhibitors in Youth with Pediatric Chronic Kidney Disease
Led by Ann & Robert H Lurie Children's Hospital of Chicago · Updated on 2026-02-20
40
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
A
Ann & Robert H Lurie Children's Hospital of Chicago
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating if a clinical trial using sodium-glucose co-transporter 2 inhibitors (SGLT2i), specifically empagliflozin, is possible for youth with chronic kidney disease (CKD). The study aims to find out whether giving empagliflozin to young people with CKD for three months can lead to improvements in blood, urine, and heart function tests. This early phase 1 trial will also assess how feasible it is to enroll 40 youth with CKD into such a study. Participants will be randomly assigned to one of two groups: one group will take empagliflozin 10 mg once daily for three months, while the other group will continue with their usual care without empagliflozin. Those in the treatment group will have clinic visits at 4 and 8 weeks after starting the drug for check-ups and tests. All participants will have clinic visits at the beginning and end of the study period to collect health information and perform tests. During the study, researchers will conduct phone check-ins every two weeks with participants. They will monitor key health measures including blood pressure, urine albumin to creatinine ratio, and heart strain tests. The main outcome is the percentage of participants who complete all study procedures over four years. The total participation time for each participant is about three months. Safety and adherence will be closely monitored throughout the trial.
CONDITIONS
Brief Title
Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Youth aged 12 to 25 years
- Stage 3-4 chronic kidney disease with estimated glomerular filtration rate (eGFR) between 20 and 60 mL/min/1.73m2 using CKiD U25-creatinine equation
You will not qualify if you...
- 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 need for intermittent urinary catheterization
- Systolic blood pressure less than 100 mmHg
- Orthostatic hypotension
- Current use of an SGLT2 inhibitor
- Anticipated need for anti-hypertensive medication changes within 3 months
- Active use of any immunosuppressive medications
- Lack of clearance by primary nephrologist for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 months
Participants receive Empagliflozin 10mg daily or standard care for pediatric chronic kidney disease.
Regular visits during treatment period
Trial Site Locations
Total: 1 location
1
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
A
Alexander J Kula, MD, MHS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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