Peritoneal Dialysis ComplicationPhase 3CANARYNCT05715814
meChANisms and sAfety of SGLT2 Inhibition in peRitoneal dialYsis
A Phase 3 study testing Empagliflozin 25 MG in people with Peritoneal Dialysis Complication and End Stage Kidney Disease, run by University Health Network, Toronto at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dialysis Complication, End Stage Kidney Disease, Sodium-glucose Co-transporter-2 Inhibitors
- What is being tested?
- Empagliflozin 25 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2024to 1 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G2N2
Vesta Lai, 416-340-4800 ext. 8508, vesta.lai@uhn.ca
About this study
Official title: A Single Arm, Open Label, Pilot Study to Evaluate the Safety and Efficacy of Once Daily 25mg Empagliflozin in Patients on Peritoneal Dialysis With Residual Kidney Function
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).
Read the detailed description
The importance of RKF on the survival of patients on PD has been demonstrated in several observational studies. Despite this, there are limited pharmacological interventions available to slow the loss of RKF in these patients. There is an unmet need for novel cardiovascular and kidney protective strategies for patients on renal replacement therapies, including PD.
SGLT2 inhibitors have been shown to have both cardiovascular and kidney protective effects in individuals with kidney disease, with and without diabetes. These benefits have been attributed to diverse mechanisms and kidney benefits have been largely attributed to reductions in intraglomerular pressure at the single nephron level, reversibly lowering GFR in the short-term with long-term benefits. However, the beneficial effects of SGLT2 inhibitors have never been studied in patients on dialysis.
The CANARY study will provide insight into the safety and mechanisms of SGLT2 inhibitors in individuals on dialysis with RKF, with and without type 2 diabetes, over a period of 2 weeks. Demonstrating that protective mechanisms associated with SGLT2 inhibitors are intact in patients on PD with RKF would provide a strong rationale for a larger clinical trial to explore the use of these novel drugs in this unique clinical application. Additionally, our proposed study would provide timely mechanistic data to inform clinical decisions in the context of other large clinical trials such as EMPA-KIDNEY. These findings would help physicians make decisions on leaving patients on SGLT2 inhibitors even beyond end-stage kidney disease.
- Conditions
- Peritoneal Dialysis Complication, End Stage Kidney Disease, Sodium-glucose Co-transporter-2 Inhibitors, Kidney Dysfunction, Residual Kidney Function
- Being tested
- Empagliflozin 25 MG
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 25 MGDrug
Also called JARDIANCE
PO once daily
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Experimental | Not described Receives: Drug: Empagliflozin 25 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in measured GFR
GFR will be determined from the average of creatinine and urea clearance from a 24-hour urine collection.
Measured: Before and 2 weeks after initiation of empagliflozin.
Secondary outcomes (17)
Rebound in GFR after Cessation of Therapy
A GFR measurement will be performed 2 weeks after cessation of empagliflozin, with the aim of capturing the reversible "rebound" in GFR after cessation of therapy.
Measured: 2 weeks
Change in ultrafiltration volume
Measured: 2 weeks
Change in fraction of glucose remaining in the dialysate
Measured: 2 weeks
Change in dialysate/plasma creatinine
Measured: 2 weeks
Change in dialysate/plasma urea
Measured: 2 weeks
Change in sodium dialysate concentration
Measured: 2 weeks
Change in glycated hemoglobin (HbA1c)
Measured: 2 weeks
Change in systolic and diastolic blood pressure
Measured: 2 weeks
Change in body weight
Measured: 2 weeks
Change in body composition (percent body mass, body fat, and muscle mass)
Bioimpedence measurements will be taken to study the effects of intervention on body composition.
Measured: 2 weeks
Change in fractional urine excretion of sodium
Urinary analysis will be performed to quantify the amount of sodium excretion.
Measured: 2 weeks
Change in fractional urine excretion of glucose
Urinary analysis will be performed to quantify the amount of glucose excretion.
Measured: 2 weeks
Change in eGFRβ2-microglobulin
Blood sample analysis to assess middle molecule clearance.
Measured: 2 weeks
Change in degree of albuminuria
Urinary analysis will be performed to determine if there has been any change in the severity of albuminuria
Measured: 2 weeks
Change in BNP (NT-proB-type Natriuretic Peptide)
Measured: 2 weeks
Change in markers of neurohumoral activation, erythropoiesis, and inflammation.
Measured: 2 weeks
The safety of empaglifllozin use in PD patients with RKF with regard to anuria (<100cc/day), volume depletion, diabetic ketoacidosis, genito-urinary infections, PD peritonitis and death will be evaluated.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Sep 2024
- Primary completion1 May 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Dialysis ComplicationStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunita Singh, MD, MSc, FRCPC, University Health Network, Toronto
- Investigators
- Sunita KS Singh, MD MSc FRCPC, Principal investigator, University Health Network, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715814
- Sponsor's protocol ID
- 21-6198
- Acronym
- CANARY
- Status last verified
- Apr 2026
- First submitted
- 18 Jan 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open Label, Pilot Study to Evaluate the Safety and Efficacy of Once Daily 25mg Empagliflozin in Patients on Peritoneal Dialysis With Residual Kidney Function
- ClinicalTrials.gov ID
- NCT05715814
- Acronym / sponsor ID
- CANARY / 21-6198
- Conditions
- Peritoneal Dialysis Complication, End Stage Kidney Disease, Sodium-glucose Co-transporter-2 Inhibitors, Kidney Dysfunction, Residual Kidney Function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The importance of RKF on the survival of patients on PD has been demonstrated in several observational studies. Despite this, there are limited pharmacological interventions available to slow the loss of RKF in these patients. There is an unmet need for novel cardiovascular and kidney protective strategies for patients on renal replacement therapies, including PD.
SGLT2 inhibitors have been shown to have both cardiovascular and kidney protective effects in individuals with kidney disease, with and without diabetes. These benefits have been attributed to diverse mechanisms and kidney benefits have been largely attributed to reductions in intraglomerular pressure at the single nephron level, reversibly lowering GFR in the short-term with long-term benefits. However, the beneficial effects of SGLT2 inhibitors have never been studied in patients on dialysis.
The CANARY study will provide insight into the safety and mechanisms of SGLT2 inhibitors in individuals on dialysis with RKF, with and without type 2 diabetes, over a period of 2 weeks. Demonstrating that protective mechanisms associated with SGLT2 inhibitors are intact in patients on PD with RKF would provide a strong rationale for a larger clinical trial to explore the use of these novel drugs in this unique clinical application. Additionally, our proposed study would provide timely mechanistic data to inform clinical decisions in the context of other large clinical trials such as EMPA-KIDNEY. These findings would help physicians make decisions on leaving patients on SGLT2 inhibitors even beyond end-stage kidney disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Experimental | Drug: Empagliflozin 25 MG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 25 MGAlso: JARDIANCEPO once daily | Drug | Empagliflozin |
Primary outcome
Change in measured GFR
Time frame: Before and 2 weeks after initiation of empagliflozin.
GFR will be determined from the average of creatinine and urea clearance from a 24-hour urine collection.
17 secondary outcomes
Rebound in GFR after Cessation of Therapy
Time frame: 2 weeks
Change in ultrafiltration volume
Time frame: 2 weeks
Change in fraction of glucose remaining in the dialysate
Time frame: 2 weeks
Change in dialysate/plasma creatinine
Time frame: 2 weeks
Change in dialysate/plasma urea
Time frame: 2 weeks
Change in sodium dialysate concentration
Time frame: 2 weeks
Change in glycated hemoglobin (HbA1c)
Time frame: 2 weeks
Change in systolic and diastolic blood pressure
Time frame: 2 weeks
Change in body weight
Time frame: 2 weeks
Change in body composition (percent body mass, body fat, and muscle mass)
Time frame: 2 weeks
Change in fractional urine excretion of sodium
Time frame: 2 weeks
Change in fractional urine excretion of glucose
Time frame: 2 weeks
Change in eGFRβ2-microglobulin
Time frame: 2 weeks
Change in degree of albuminuria
Time frame: 2 weeks
Change in BNP (NT-proB-type Natriuretic Peptide)
Time frame: 2 weeks
Change in markers of neurohumoral activation, erythropoiesis, and inflammation.
Time frame: 2 weeks
The safety of empaglifllozin use in PD patients with RKF with regard to anuria (<100cc/day), volume depletion, diabetic ketoacidosis, genito-urinary infections, PD peritonitis and death will be evaluated.
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Peritoneal Dialysis Complication
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
Not yet recruiting
Days-Off Versus Daily Initial Peritoneal Dialysis Prescription
Kidney Failure
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
RecruitingPhase 2
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
End Stage Renal Disease on Dialysis, Peritoneal Dialysis Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sunita KS Singh, MD MSc FRCPC principal investigator
University Health Network, Toronto General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Empagliflozin 25 MG in people with Peritoneal Dialysis Complication and End Stage Kidney Disease, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vesta Lai (416-340-4800 ext. 8508, vesta.lai@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in measured GFR (time frame: Before and 2 weeks after initiation of empagliflozin.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.