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Can a diabetes drug help dialysis patients keep their kidneys working?

NCT ID NCT05715814

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a daily 25 mg dose of empagliflozin (a diabetes drug) is safe and helps preserve remaining kidney function in 20 adults on peritoneal dialysis. Participants must still produce at least 250 mL of urine daily. The trial measures changes in kidney filtration rate and looks for a possible rebound effect after stopping the drug.

What this could mean

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

Active substance
empagliflozin (25 mg once daily)
What this could lead to
If it works, this could help people on peritoneal dialysis keep their remaining kidney function longer, potentially reducing dialysis needs.
What could go wrong
This is a small pilot study with only 20 participants, so results may not apply to everyone. Empagliflozin can cause side effects like dehydration or urinary infections.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 20 people

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

Started

Sep 2024

Expected to finish

Dec 2027

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: * Signed and dated written informed consent. * Patients aged ≥18 years on PD with RKF defined as at least 250 cc of urine output per day (assessed via 24-hour urine collection) and a minimum measured GFR of 2 ml/min/1.73m2, as measured at least once in the last 3 months. * Stable PD prescription, as determined by investigators. * Stable dose of RAAS blockade if on a medication within this class for the last 30 days. Exclusion Criteria: * Type 1 diabetes. * Recent (in the 30 days prior to screening) acute coronary syndrome or cerebrovascular event. * PD peritonitis within 30 days of screening. * History of organ transplant, including pancreas, pancreatic islet cells or kidney transplant. * Planned surgery/procedures or radiologic investigations requiring contrast during the trial. * Pregnant, planning to become pregnant, or nursing an infant during the study period * History of any DKA event * Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells (e.g., malaria, babesiosis, hemolytic anemia) at screening. * Women who are pregnant, nursing, or who plan to become pregnant whilst in the trial. * Alcohol or drug abuse within the 3 months prior to screening that would interfere with trial participation based on Investigator's judgement. * Use of SGLT2 inhibitor within 30 days prior to screening. * Intake of an investigational drug in another trial within 30 days prior to screening. * Patient not able to understand and comply with study requirements, based on Investigator's judgment. * Any other clinical condition that, based on Investigator's judgement, would jeopardize patient safety during trial participation or would affect the study outcome (e.g. immunocompromised patients, active malignancy, patients who might be at higher risk of developing genital or mycotic infections, patients with chronic viral infections, uncontrolled hypertension, cardiorenal and/or hepatorenal syndrome, severe hepatic impairments etc.).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Toronto General Hospital

    RECRUITING

    Toronto, Ontario, M5G2N2, Canada

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