Can a diabetes drug help dialysis patients keep their kidneys working?
NCT ID NCT05715814
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Toronto General Hospital
RECRUITINGToronto, Ontario, M5G2N2, Canada
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