Safety, Tolerability, and Feasibility of Empagliflozin Therapy in Dialysis-dependent ESKD
End-stage Kidney Disease, Kidney Disease, Chronic, Dialysis
About this trial
This is an interventional treatment trial for End-stage Kidney Disease
Eligibility 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
Sites / Locations
- University of UtahRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Empagliflozin 10mg
Empagliflozin 25mg
Placebo
Empagliflozin10mg oral: Those randomized to 10 mg daily dose will be treated with 10 mg QD throughout the dose escalation and the treatment phase for a total of 12 weeks.
Empagliflozin 25 mg oral: Those randomized to 25 mg daily dose will be treated with 10 mg QD for the first 2 weeks before escalating the dose to 25 mg QD in week 3, based on tolerability. At the end of the dose-escalation phase (weeks 3-4), participants will continue the randomized assignment for additional 8 weeks (weeks 5-12, treatment phase), for a total of 12 weeks.
Encapsulated placebo with an identical appearance to empagliflozin: Those randomized to placebo will be treated with an oral placebo QD throughout the dose escalation and the treatment phase for a total of 12 weeks.