Safety, Tolerability, and Feasibility of Empagliflozin Therapy in Dialysis-dependent ESKD (NCT05614115) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability, and Feasibility of Empagliflozin Therapy in Dialysis-dependent ESKD
United States62 participantsStarted 2023-03-21
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was testing empagliflozin — a diabetes drug — in people on dialysis, including non-diabetic patients. Can you explain why this drug might be relevant to my situation, even if I don't have diabetes?
2Since this was a Phase 1 trial focused on safety and feasibility rather than proving the treatment works, what do we actually know so far about whether empagliflozin is safe for dialysis patients, and are there any concerning signals I should be aware of?
3The trial has completed, so are there published results showing how many patients were able to stick with the full 12-week dose, and what does that tell us about how realistic this treatment would be for someone in my position?
4Given that this was an early-phase trial, would it make more sense for me to continue with my current standard dialysis care while larger studies catch up, or is there a reason to consider empagliflozin now?
5Are there any follow-up trials building on this completed Phase 1 study that I might be eligible for, or other research paths you'd recommend I explore given my specific diagnosis?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.