About this trial
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
This trial does not accept healthy volunteersQualifiers
Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL/min/1.73m2
Disqualifiers
Heart Disease
Diabetes
Pregnancy
Recipient of solid organ transplant
Trial design
Parallel
Treatments tested in this trial
Empagliflozin 10 MG
DrugEmpagliflozin 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
Treatment groups
Trial outcomes
Primary outcomes
Percentage of participants who complete all study procedures
Compared to the number recruited, how many participants complete the study
Secondary outcomes
Systolic Blood Pressure
In-clinic systolic blood pressure
Serum N-terminal pro-brain natruetic peptide (NT-proBNP)
Urine Albumin to Creatinine Ratio (UACr)
Left Atrial Reservoir Strain
Measuring using echocardiography
Sponsors and contacts
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Ann & Robert H Lurie Children's Hospital of Chicago
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator