Safety and Efficacy of Empagliflozin in Hemodialysis

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
NYU Langone Health
Study ID
NCT05786443
Phase
PHASE2
Status
Recruiting
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Conditions

  • End Stage Renal Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 31, 2024
Status verified
Dec 2025
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Empagliflozin
    Participants with end-stage kidney disease (ESRD) initiating hemodialysis will receive Empagliflozin 10 mg daily for 12 weeks.
  • Placebo Comparator: Placebo
    Participants with ESRD initiating hemodialysis will receive Empagliflozin-matching placebo daily for 12 weeks.

Primary Outcome Measure

Change in Extracellular Volume from Baseline to 12 Weeks [ Time Frame: Baseline, Week 12 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts021215
Finnian R. Mc Causland
[email protected]
617-732-6432
Finnian R. Mc Causland (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
David M Charytan, MS, MSc (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MANYU Langone Health· New York, NY

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