Hemodialysis Clinical Trial
Official title:
Safety, Tolerability, and Feasibility of Empagliflozin Therapy in Dialysis-dependent ESKD
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.
Status | Recruiting |
Enrollment | 75 |
Est. completion date | March 31, 2025 |
Est. primary completion date | March 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion of participants in each intervention group who remain in follow-up and adhere to the full randomized dose of empagliflozin at the end of the 12-week intervention period. | 12 weeks | ||
Secondary | Proportions of participants in each group who reduce and/or discontinue treatment for safety | Safety outcomes (to be assessed in each treatment group):
Proportions of participants with any of the following prespecified adverse events of interest: (i) Severe hypoglycemia1; (ii) Ketoacidosis; (iii) Hypotension; (iv) Genital infection; (v) Hepatic injury Composite of the individual components of the prespecified adverse events of interest (i) through (v) Occurrence of any hospitalization and/or visit to Emergency Department |
12-weeks | |
Secondary | Proportions of participants in each group who reduce and/or discontinue treatment because of intolerance (i.e., allergy, nausea) or other reasons unrelated to safety (i.e., pill burden, study withdrawal due to transplant) | 12-weeks | ||
Secondary | Proportions of participants in each group who have = 80% pill count compliance. | 12-weeks | ||
Secondary | Dialytic clearance of empagliflozin | 4 hours post-dose during hemodialysis | ||
Secondary | Long-term accumulation of empagliflozin | 10 weeks |
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