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NCT05614115CompletedPhase 1

Safety, Tolerability, and Feasibility of Empagliflozin Therapy in Dialysis-dependent ESKD

Source: ClinicalTrials.gov · Last updated 30 Oct 2026

Brief summary (registry, in English)

The purpose of this study is to find out if empagliflozin, a new diabetic medication that has been shown to be very effective in lowering the risk of heart failure, is safe and tolerated in dialysis patients. In the recent years, empagliflozin has become a major tool to prevent heart failure hospitalization and to reduce the risk for cardiovascular death in diabetic and non-diabetic patients. Although patients with severe chronic kidney disease and ESKD have very high risk of heart failure and cardiovascular death, they have been excluded from all of the previous studies. If this medication is found to be well tolerated and safe in dialysis patients through this study, future clinical studies can evaluate if this medication can also reduce the risk of heart failure and cardiovascular death in dialysis patients.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
62 (actual)
First submitted
26 Oct 2022
Start date
Mar 2023
Primary completion date
Jun 2025
Lead sponsor
University of Utah
NCT number
NCT05614115

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 62
  • From Mar 2023 to the primary completion date, Jun 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • type 1 diabetes
  • ongoing intravenous antibiotic therapy for infectious disease
  • active treatment for malignancy
  • history of Fournier's gangrene
  • allergy to empagliflozin

Other

  • unhealed lower extremity skin ulceration
  • diabetic ketoacidosis
  • severe hypoglycemia (requiring external assistance within the past one year)
  • pregnancy

Who the study is looking for

  • include diabetic and non-diabetic adults
  • dialysis treatment history of ≥3 months

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Utah
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.