drugset / Trial / NCT05614115

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

NCT05614115

RandomizedSequentialQuadruple-blindTreatment

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.

Timeline

Start
2023-03-21
Primary completion
2025-06-30
Completion
2025-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Empagliflozin Small molecule 10 mg Oral
Subject Empagliflozin Small molecule 25 mg Oral