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Recruiting NCT06430684

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

Conditions: Chronic Kidney Diseases, Pediatric Kidney Disease

Sex: All
Ages: 12 Years – 25 Years
Healthy volunteers: No
Phase: EARLY_PHASE1
Enrollment: 40
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Location: Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois

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

Eligibility 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 \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06430684). StuddyBuddy aggregates publicly available trial information.