Actively Recruiting
Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in 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
96 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
The goal of this study is to learn if a clinical trial of sodium-glucose co-transporter 2 inhibitors (SGLT2i) is possible in youth with chronic kidney disease (CKD). The investigators also plan to explore whether treatment with SGLT2i (Empagliflozin) helps improve risk factors for worsening kidney and heart disease. The main questions are: 1. Is enrolling 40 youth with CKD into a clinical trial of empagliflozin feasible (ie achievable)? 2. Does taking empagliflozin for 3 months result in positive changes in blood, urine, and heart function tests? Participants will be randomly selected (like flipping a coin) to either receive empagliflozin or not start treatment with empagliflozin and remain on their usual care. Study Procedures Include * For participants randomly selected for treatment, take empagliflozin once daily for 3 months * Phone calls with researchers every 2 weeks for check-ins * For participants taking empagliflozin, clinic visits 4 and 8 weeks after starting for check-ups and tests * All study participants will have clinic visits at the beginning and end (3 months) where researchers will collect information about their health and perform tests
CONDITIONS
Official Title
Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Stage 3-4 chronic kidney disease with estimated glomerular filtration rate 20-60 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 titration of anti-hypertensive medications within 3 months
- Active use of any immunosuppressive medications
- Lack of clearance by primary nephrologist for participation
AI-Screening
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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
CONTACT
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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