Trials / Recruiting
RecruitingNCT05786443
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- NYU Langone Health · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-01-31
- Primary completion
- 2026-12-30
- Completion
- 2026-12-30
- First posted
- 2023-03-27
- Last updated
- 2025-12-04
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05786443. Inclusion in this directory is not an endorsement.