Safety and Efficacy of Empagliflozin in Hemodialysis

NCT05786443 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-04

No results posted yet for this study

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

Placebo

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

Sponsors & Collaborators

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05786443 on ClinicalTrials.gov