Empagliflozin in ESKD - A Feasibility Study
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.
Conditions:
🦠 Kidney Failure, Chronic 🦠 Heart Failure
🗓️ Study Start (Actual) 1 November 2023
🗓️ Primary Completion (Estimated) 31 August 2024
✅ Study Completion (Estimated) 31 December 2024
👥 Enrollment (Estimated) 24
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Jackson, Mississippi, United States
📍 Jackson, Mississippi, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. age ≥18 years;
    • 2. diagnosis of end-stage kidney disease requiring dialysis, and
    • 3. ability to provide informed consent.

    Exclusion Criteria:

    • 1. systolic blood pressure \<100 mm Hg (pre-dialysis for HD patients)
    • 2. two or more episodes of urinary tract infection within the last 12 months
    • 3. history of urinary retention or urinary tract obstruction
    • 4. liver cirrhosis
    • 5. advanced heart failure requiring heart assist device or inotropic support
    • 6. heart or liver transplant recipient
    • 7. major surgery performed within the last 3 months ("major" per the investigator's assessment)
    • 8. major surgery scheduled within 3 months after screening ("major" per the investigator's assessment)
    • 9. active cancer
    • 10. pregnant or lactating women
    • 11. known allergy or hypersensitivity to any SGLT2 inhibitors
    • 12. history of ketoacidosis during the last 12 months
    • 13. any other medical condition considered unappropriated by their nephrologists or a study physician (i.e., cachexia, short life expectancy, or uncontrolled personality/phycological disorder).
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 16 September 2022
  • First Submitted that Met QC Criteria 12 January 2023
  • First Posted 17 January 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 7 March 2024
  • Last Update Posted 12 March 2024
  • Last Verified March 2024