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

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

CT.gov Identifier
EudraCT Identifier
N/A
CTIS:
N/A
Sponsor
National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases
Collaborator
Ann & Robert H. Lurie Children's Hospital of Chicago {Children's Memorial Hospital}
Study Contact Information
N/A
Recruiting
Contact Us

Study Details

Diseases
Chronic Kidney Disease
Study Drug
Empagliflozin
See More
Undisclosed - renal disease therapy
Genes
N/A
Study Dates
Aug 2024 - Jun 2026
Sex
Female & Male
Age
12 - 25 Years

Protocol 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

Study Locations

To view all trial locations, click here

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