Recruiting

Phase 3

SGLT2 InhibitionmeChANisms and sAfety of SGLT2 Inhibition in peRitoneal dialYsis

Sponsor:

University Health Network, Toronto

Code:

NCT05715814

Conditions

Peritoneal Dialysis Complication

End Stage Kidney Disease

Sodium-glucose Co-transporter-2 Inhibitors

Kidney Dysfunction

Residual Kidney Function

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Empagliflozin 25 MG

Study Details

Brief summary:

The primary aim of this study is to determine the safety and mechanisms of SGLT2 inhibition in individuals on peritoneal dialysis (PD) with residual kidney function (RKF).

Conditions

Peritoneal Dialysis Complication

End Stage Kidney Disease

Sodium-glucose Co-transporter-2 Inhibitors

Kidney Dysfunction

Residual Kidney Function

Study ID

NCT05715814

Start date

Sep 1, 2024

Status verified date

Apr, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.).

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Empagliflozin

Interventions

Empagliflozin 25 MG

PO once daily

Primary outcome measure

Change in measured GFR [ Time Frame: Before and 2 weeks after initiation of empagliflozin. ]

Central Contacts and Locations

Central contacts

Vesta Lai

416-340-4800 vesta.lai@uhn.ca

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G2N2

Contacts

Vesta Lai

416-340-4800 vesta.lai@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-05-01.