Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease

Recruiting now · Early Phase 1

Conditions studied: Chronic Kidney Diseases, Pediatric Kidney Disease

In brief

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

Key facts

Study ID

NCT06430684

Run by

Ann & Robert H Lurie Children's Hospital of Chicago

People needed

40

Starts

2024-08-23

Expected to finish

2026-07-01

Last updated by the study team

2026-02-20

Who can join

Age: 12 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL/min/1.73m2

You may not qualify if…

• 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 is running

• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.