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

NYU Langone Health

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

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Adults ≥18 years on maintenance hemodialysis (HD) with residual kidney function * Thrice-weekly HD * Willingness and capacity to provide informed consent * For women of childbearing potential, a negative pregnancy test is required at screening Exclusion Criteria: * Does not have capacity to consent * Anuria (daily urine volume \< 200 mL/day) * Planned kidney transplant within 3 months * Recurrent urinary tract infections (\>2 episodes/year or antibiotic prophylaxis) * New York Heart Association (NYHA) Class IV heart failure (HF) * Myocardial infarction, unstable angina…

Interventions

Drug
Empagliflozin 10 MG
Sodium glucose cotransporter 2 inhibitor (SGLT2i) dosed once-daily over 12 weeks. Administered as oral tablet.
Drug
Placebo
Empagliflozin-matching placebo dosed once-daily over 12 weeks. Administered as oral tablet.

Locations (2)

Brigham and Women's Hospital
Boston, Massachusetts
fmccausland@bwh.harvard.edu 617-732-6432
NYU Langone Health
New York, New York

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

Summary

Eligibility

Interventions

Locations (2)

Compensation

Run this study?

Details

Conditions