| Trial ID: | L1162 |
| Source ID: | NCT05614115
|
| Associated Drug: |
Empagliflozin
|
| Title: |
Safety, Tolerability, and Feasibility of Empagliflozin Therapy in Dialysis-dependent ESKD
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End-stage Kidney Disease|Kidney Disease, Chronic|Dialysis|Diabetic|Non-diabetic|Kidney Dysfunction|Kidney Failure|Hemodialysis
|
| Interventions: |
DRUG: Empagliflozin|OTHER: Placebo
|
| Outcome Measures: |
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): 1. 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 2. Composite of the individual components of the prespecified adverse events of interest (i) through (v) 3. Occurrence of any hospitalization and/or visit to Emergency Department, 12-weeks|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|Proportions of participants in each group who have ≥ 80% pill count compliance., 12-weeks|Dialytic clearance of empagliflozin, 4 hours post-dose during hemodialysis|Long-term accumulation of empagliflozin, 10 weeks
|
| Sponsor/Collaborators: |
Sponsor: University of Utah | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
75
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2023-03-21
|
| Completion Date: |
2025-03-31
|
| Results First Posted: |
|
| Last Update Posted: |
2024-05-02
|
| Locations: |
University of Utah, Salt Lake City, Utah, 84132, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05614115
|
