Feasibility Trial of Sodium-GLucose CoTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease
Status:
RECRUITING
Trial end date:
2026-06-01
Target enrollment:
Participant gender:
Summary
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
Phase:
EARLY_PHASE1
Details
Lead Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)