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

• Status: Not yet recruiting
• Trial end date: 2025-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

• include diabetic and non-diabetic adults

• dialysis treatment history of ≥3 months

Exclusion Criteria:

• type 1 diabetes

• ongoing intravenous antibiotic therapy for infectious disease

• active treatment for malignancy

• unhealed lower extremity skin ulceration

• history of Fournier's gangrene

• diabetic ketoacidosis

• severe hypoglycemia (requiring external assistance within the past one year)

• allergy to empagliflozin

• pregnancy