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Can a diabetes drug help dialysis patients? small study aims to find out

NCT ID NCT05687058

Knowledge-focused Sponsor: University of Mississippi Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study is testing whether the diabetes and heart failure drug empagliflozin (Jardiance) is safe for people on dialysis for kidney failure. The drug is already approved for other uses but has not been studied in dialysis patients. Researchers will give 24 participants either a thrice-weekly or daily dose for three months, monitoring safety and how well they tolerate it. The goal is to gather information needed for a larger future trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Empagliflozin (Jardiance)
What this could lead to
If this study shows the drug is safe, it could pave the way for a larger trial testing whether empagliflozin protects the heart and remaining kidney function in dialysis patients.
What could go wrong
This is a very small, early feasibility study with only 24 participants. It is not designed to prove the drug works, and the drug has not been approved for dialysis patients. Safety risks are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. age ≥18 years; 2. diagnosis of end-stage kidney disease requiring dialysis, and 3. ability to provide informed consent. Exclusion Criteria: 1. systolic blood pressure \<100 mm Hg (pre-dialysis for HD patients) 2. two or more episodes of urinary tract infection within the last 12 months 3. history of urinary retention or urinary tract obstruction 4. liver cirrhosis 5. advanced heart failure requiring heart assist device or inotropic support 6. heart or liver transplant recipient 7. major surgery performed within the last 3 months ("major" per the investigator's assessment) 8. major surgery scheduled within 3 months after screening ("major" per the investigator's assessment) 9. active cancer 10. pregnant or lactating women 11. known allergy or hypersensitivity to any SGLT2 inhibitors 12. history of ketoacidosis during the last 12 months 13. any other medical condition considered unappropriated by their nephrologists or a study physician (i.e., cachexia, short life expectancy, or uncontrolled personality/phycological disorder).

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome end stage renal failure heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure Kidney failure, chronic

Contacts and locations

Locations

  • Jackson Medicall Mall Dialysis Clinic

    Jackson, Mississippi, 39213, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39157, United States

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