meChANisms and sAfety of SGLT2 Inhibition in peRitoneal dialYsis

NCT ID: NCT05715814

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-12-01

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).

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Empagliflozin

Group Type: EXPERIMENTAL

Empagliflozin 25 MG

Intervention Type: DRUG

PO once daily

Interventions

Empagliflozin 25 MG

PO once daily

Intervention Type: DRUG

Other Intervention Names

JARDIANCE

Eligibility Criteria

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.).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Sunita Singh, MD, MSc, FRCPC

Clinician Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sunita KS Singh, MD MSc FRCPC

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto General Hospital

Locations

Toronto General Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Vesta Lai

Role: CONTACT

vesta.lai@uhn.ca

416-340-4800 ext. 8508

Facility Contacts

Vesta Lai

Role: primary

vesta.lai@uhn.ca

416-340-4800 ext. 8508

Other Identifiers

21-6198

Identifier Type: -

Identifier Source: org_study_id