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NCT05687058
Empagliflozin in ESKD - A Feasibility Study
Conditions: Kidney Failure, Chronic, Heart Failure
Sex: All
Ages: 18 Years – N/A
Phase: PHASE1, PHASE2
Enrollment: 24
Sponsor: University of Mississippi Medical Center
Location: United States
Summary
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.
Eligibility Criteria
Inclusion Criteria:age ≥18 years;diagnosis of end-stage kidney disease requiring dialysis, andability to provide informed consent.Exclusion Criteria:systolic blood pressure <100 mm Hg (pre-dialysis for HD patients)two or more episodes of urinary tract infection within the last 12 monthshistory of urinary retention or urinary tract obstructionliver cirrhosisadvanced heart failure requiring heart assist device or inotropic supportheart or liver transplant recipientmajor 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)active cancerpregnant or lactating womenknown allergy or hypersensitivity to any SGLT2 inhibitorshistory of ketoacidosis during the last 12 monthsany other medical condition considered unappropriated by their nephrologists or a study physician (i.e., cachexia, short life expectancy, or uncontrolled personality/phycological disorder).
Source: ClinicalTrials.gov (NCT05687058). StuddyBuddy aggregates publicly available trial information.