Safety and Efficacy of Empagliflozin in Hemodialysis
NCT05786443 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-12-04
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.
Conditions
Interventions
- DRUG
-
Empagliflozin 10 MG
Sodium glucose cotransporter 2 inhibitor (SGLT2i) dosed once-daily over 12 weeks. Administered as oral tablet.
- DRUG
-
Empagliflozin-matching placebo dosed once-daily over 12 weeks. Administered as oral tablet.
Sponsors & Collaborators
-
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
collaborator NIH - collaborator INDUSTRY
- lead OTHER
Principal Investigators
-
David Charytan, MS, MSc · NYU Langone Health
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-31
- Primary Completion
- 2026-12-30
- Completion
- 2026-12-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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