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Not Yet Recruiting
NCT05614115
Safety, Tolerability, and Feasibility of Empagliflozin Therapy in Dialysis-dependent ESKD
Conditions: End-stage Kidney Disease, Kidney Disease, Chronic, Dialysis, Diabetic, Non-diabetic, Kidney Dysfunction, Kidney Failure, Hemodialysis
Sex: All
Ages: 18 Years – N/A
Phase: PHASE1
Enrollment: 75
Sponsor: University of Utah
Summary
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.
Eligibility Criteria
Inclusion Criteria:include diabetic and non-diabetic adultsdialysis treatment history of ≥3 monthsExclusion Criteria:type 1 diabetesongoing intravenous antibiotic therapy for infectious diseaseactive treatment for malignancyunhealed lower extremity skin ulcerationhistory of Fournier's gangrenediabetic ketoacidosissevere hypoglycemia (requiring external assistance within the past one year)allergy to empagliflozinpregnancy
Source: ClinicalTrials.gov (NCT05614115). StuddyBuddy aggregates publicly available trial information.