Active — Not RecruitingPhase 1/2

Empagliflozin in ESKD - A Feasibility Study

United States24 participantsStarted 2023-11-01

Plain-language summary

The aim of this study is to learn about the safety of empagliflozin in dialysis patients as a preparation for a future large clinical trial. Empagliflozin has been approved by the Food and Drug Administration for the treatment of either type 2 diabetes, heart failure, or chronic kidney disease among patients not on dialysis. The use of empagliflozin has not been studied or approved among patients on dialysis for kidney failure because empagliflozin acts on the kidneys. However, recent experimental studies have indicated that empagliflozin may provide direct heart benefits. Some dialysis patients have substantial residual kidney function, which may be protected by empagliflozin. Participants will be given empagliflozin for three (3) months on top of the standard of care (usual medical care for participants' condition) and will be followed up until one (1) month after the last dose. The investigators will collect information about participants' general health, obtain blood, urine, and imaging studies, check home blood pressure, monitor home blood sugar levels, and ask health-related questions to assess the safety and potential benefits of empagliflozin over four (4) months, including one month before the three (3)-month empagliflozin treatment.

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

. age ≥18 years;
. diagnosis of end-stage kidney disease requiring dialysis, and
. ability to provide informed consent.

Exclusion criteria

. systolic blood pressure \<100 mm Hg (pre-dialysis for HD patients)
. two or more episodes of urinary tract infection within the last 12 months
. history of urinary retention or urinary tract obstruction
. liver cirrhosis

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Proportion of eligible patients out of screened patients

Timeframe: During the screening process

Success rate of obtaining consent from those eligible patients

Timeframe: During the enrollment process

Proportion of missing doses

Timeframe: 3 months

Proportion of empagliflozin discontinuation

Timeframe: 3 months

Dropout rate

Timeframe: 3 months

Length of time on continuous glucose monitoring

Timeframe: 3 months

Completion rate of timed urine collection

Timeframe: 3 months

Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis

Trial details

NCT IDNCT05687058

SponsorUniversity of Mississippi Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-04

View on ClinicalTrials.gov More Kidney Failure, Chronic trials

Plain-language summary

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

. age ≥18 years;
. diagnosis of end-stage kidney disease requiring dialysis, and
. ability to provide informed consent.

Exclusion criteria

. systolic blood pressure \<100 mm Hg (pre-dialysis for HD patients)
. two or more episodes of urinary tract infection within the last 12 months
. history of urinary retention or urinary tract obstruction
. liver cirrhosis

What they're measuring

Proportion of eligible patients out of screened patients

Timeframe: During the screening process

Success rate of obtaining consent from those eligible patients

Timeframe: During the enrollment process

Proportion of missing doses

Timeframe: 3 months

Proportion of empagliflozin discontinuation

Timeframe: 3 months

Dropout rate

Timeframe: 3 months

Length of time on continuous glucose monitoring

Timeframe: 3 months

Completion rate of timed urine collection

Timeframe: 3 months

Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis