RecruitingPhase 2NCT05786443

Safety and Efficacy of Empagliflozin in Hemodialysis

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Empagliflozin Among Patients Initiating Hemodialysis for the Treatment of End-Stage Kidney Disease


Sponsor

NYU Langone Health

Enrollment

60 participants

Start Date

Jan 31, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

A 12-week, phase II, randomized, double-blind, placebo-controlled, multi-center study to assess the safety, tolerability, and preliminary efficacy of empagliflozin versus placebo among patients initiating hemodialysis (n=60) for the treatment of end-stage kidney disease.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a diabetes medication called empagliflozin (commonly used for blood sugar and heart health) is safe and helpful for people on regular dialysis who still produce some urine. Researchers want to know if it can improve outcomes for dialysis patients with remaining kidney function. **You may be eligible if...** - You are 18 or older and on maintenance hemodialysis (dialysis 3 times per week) - You still produce some urine (at least 200 mL per day) - You are willing and able to give informed consent **You may NOT be eligible if...** - You produce very little to no urine - You are scheduled for a kidney transplant within 3 months - You have had more than 2 urinary tract infections per year - You have severe heart failure (Class IV) or recently had a heart attack or stroke - You have Type 1 diabetes or a history of diabetic ketoacidosis - You have active cancer being treated with chemotherapy or radiation - You recently had major surgery or an amputation - You have significant liver disease 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGEmpagliflozin 10 MG

Sodium glucose cotransporter 2 inhibitor (SGLT2i) dosed once-daily over 12 weeks. Administered as oral tablet.

DRUGPlacebo

Empagliflozin-matching placebo dosed once-daily over 12 weeks. Administered as oral tablet.


Locations(2)

Brigham and Women's Hospital

Boston, Massachusetts, United States

NYU Langone Health

New York, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05786443


Related Trials