Empagliflozin in ESKD - A Feasibility Study

To learn about the safety of empagliflozin in dialysis patients as a preparation for a future large clinical trial. Participants will be given empagliflozin for three (3) months on top of the standard of care (usual medical care for your condition) and will be followed up until one (1) month after the last dose. We will collect information about your 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.

CT.gov Identifier
NCT05687058
EudraCT Identifier
N/A
CTIS:
N/A
Sponsor
Eli Lilly
Collaborator
(Other Hospital/Academic/Medical Center)
Study Contact Information
+1 317 276 2000
Recruiting
Contact Us

Study Details

Diseases
Chronic Kidney Disease
Study Drug
Empagliflozin
Genes
N/A
Study Dates
Nov 2023 - Oct 2025
Sex
Female & Male
Age
18+ years
Inclusion and Exclusion Criteria
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 (

Protocol Summary

To learn about the safety of empagliflozin in dialysis patients as a preparation for a future large clinical trial.

Participants will be given empagliflozin for three (3) months on top of the standard of care (usual medical care for your condition) and will be followed up until one (1) month after the last dose. We will collect information about your 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.

Study Locations

To view all trial locations, click here

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