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Empagliflozin in ESKD - A Feasibility Study

StatusActive, Not Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Primary completion date changed from estimate of Oct 30, 2025 to May 4, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 31, 2025 to Jun 20, 2026
    • Site details revised at 2 of 2 sites
    v11
  2. Primary completion date: Apr 30, 2025 to Oct 30, 2025
    • Study completion date: Jul 31, 2025 to Dec 31, 2025
    • Site details revised at 1 of 2 sites
    v10
  3. Primary completion date: Aug 31, 2024 to Apr 30, 2025
    • Study completion date: Dec 31, 2024 to Jul 31, 2025
    v9
  4. Primary completion date: Jun 30, 2024 to Aug 31, 2024
    • Study completion date: Sep 30, 2024 to Dec 31, 2024
    • Collaborators shortened, about 4 words
    v8
  5. Trial status: Not Yet Recruiting to Recruitingv7 Show 5 more changesShow less
    • Study sites: 1 to 2
    • Primary completion date: Mar 31, 2024 to Jun 30, 2024
    • Study completion date: Jun 30, 2024 to Sep 30, 2024
    • Start date changed from estimate of Oct 1, 2023 to Nov 1, 2023
    • Secondary endpoints: 27 to 66
Show 5 earlier versionsHide 5 earlier versions
  1. Start date: Jun 1, 2023 to Oct 1, 2023
    • Primary completion date: Oct 30, 2023 to Mar 31, 2024
    • Study completion date: Dec 31, 2023 to Jun 30, 2024
    v6
  2. Primary completion date: Sep 2023 to Oct 30, 2023
    • Study completion date: Dec 2023 to Dec 31, 2023
    • Start date: Jun 2023 to Jun 1, 2023
    v5
  3. Re-verified, no change to tracked fieldsv4
  4. Start date: Feb 2023 to Jun 2023
    • Secondary endpoints: details revised at 1 of 27 entries
    v3
  5. Start date: Jan 2023 to Feb 2023
    • Secondary endpoints: details revised at 5 of 27 entries
    • Study description expanded, about 2 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The aim of this study is to learn about the safety of empagliflozin in dialysis patients as a preparation for a future large clinical trial. Empagliflozin has been approved by the Food and Drug Administration for the treatment of either type 2 diabetes, heart failure, or chronic kidney disease among patients not on dialysis. The use of empagliflozin has not been studied or approved among patients on dialysis for kidney failure because empagliflozin acts on the kidneys. However, recent experimental studies have indicated that empagliflozin may provide direct heart benefits. Some dialysis patients have substantial residual kidney function, which may be protected by empagliflozin. Participants will be given empagliflozin for three (3) months on top of the standard of care (usual medical care for participants' condition) and will be followed up until one (1) month after the last dose. The investigators will collect information about participants' general health, obtain blood, urine, and imaging studies, check home blood pressure, monitor home blood sugar levels, and ask health-related questions to assess the safety and potential benefits of empagliflozin over four (4) months, including one month before the three (3)-month empagliflozin treatment.
Trial Details
NCT Number NCT05687058
Lead Sponsor University of Mississippi Medical Center
Conditions
(from sponsor)		 Kidney Failure, Chronic, Heart Failure
Related terms Heart Failure, Kidney Failure, Chronic
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov