RecruitingEarly Phase 1NCT06430684

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


Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Enrollment

40 participants

Start Date

Aug 23, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 12 YearsMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a type of diabetes medication called SGLT2 inhibitors — which help the kidneys excrete excess sugar and also appear to protect kidney function — is safe and feasible in children with moderate to severe chronic kidney disease (CKD) who do not have diabetes. SGLT2 inhibitors are approved for adults with CKD but have not been well studied in children. **You may be eligible if...** - You have CKD Stage 3 or 4 (kidney filtration rate between 20 and 60 mL/min/1.73m²) **You may NOT be eligible if...** - You have heart disease or diabetes - You are pregnant - You have received a solid organ transplant - You have had chemotherapy or a stem cell transplant - You have moderate to severe persistent asthma - You have liver disease - You have Class 2 or greater obesity - You have a urinary obstruction or need intermittent urinary catheterization - You have very low blood pressure or low blood pressure upon standing - You are currently using an SGLT2 inhibitor - You are taking immunosuppressive medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEmpagliflozin 10 MG

Empagliflozin is a sodium glucose co-transporter 2 inhibitor (SGLT2i) that is approved for the treatment of chronic kidney disease (CKD) in persons aged 18 years or older


Locations(1)

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

Chicago, Illinois, United States

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NCT06430684


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