NCT05687058Active, not recruitingPhase 1/2
Empagliflozin in ESKD - A Feasibility Study
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 16 Sept 2022
- Start date
- 1 Nov 2023
- Primary completion date
- 4 May 2026
- Lead sponsor
- University of Mississippi Medical Center
- Diseases
- Chronic kidney disease, Heart failure
- NCT number
- NCT05687058
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 24
- From 1 Nov 2023 to the primary completion date, 4 May 2026
- 2 sites 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.
Prior treatment
- major surgery performed within the last 3 months ("major" per the investigator's assessment)
- major surgery scheduled within 3 months after screening ("major" per the investigator's assessment)
Other illness
- two or more episodes of urinary tract infection within the last 12 months
- history of urinary retention or urinary tract obstruction
- advanced heart failure requiring heart assist device or inotropic support
- heart or liver transplant recipient
- active cancer
- known allergy or hypersensitivity to any SGLT2 inhibitors
- history of ketoacidosis during the last 12 months
- any other medical condition considered unappropriated by their nephrologists or a study physician (i.e., cachexia, short life expectancy, or uncontrolled personality/phycological disorder).
Other
- systolic blood pressure \<100 mm Hg (pre-dialysis for HD patients)
- liver cirrhosis
- pregnant or lactating women
Who the study is looking for
- age ≥18 years;
- diagnosis of end-stage kidney disease requiring dialysis, and
- ability to provide informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Mississippi Medical Center Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| Jackson Medicall Mall Dialysis Clinic Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.