meChANisms and sAfety of SGLT2 Inhibition in peRitoneal dialYsis

Last updated: January 29, 2025
Sponsor: University Health Network, Toronto
Overall Status: Active - Recruiting

Phase

3

Condition

Focal Segmental Glomerulosclerosis

Treatment

Empagliflozin 25 MG

Clinical Study ID

NCT05715814
21-6198
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed and dated written informed consent.

  • Patients aged ≥18 years on PD with RKF defined as at least 250 cc of urine outputper day (assessed via 24-hour urine collection) and a minimum measured GFR of 2ml/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 30days.

Exclusion

Exclusion Criteria:

  • Type 1 diabetes.

  • Recent (in the 30 days prior to screening) acute coronary syndrome orcerebrovascular event.

  • PD peritonitis within 30 days of screening.

  • History of organ transplant, including pancreas, pancreatic islet cells or kidneytransplant.

  • Planned surgery/procedures or radiologic investigations requiring contrast duringthe 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 interferewith 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 toscreening.

  • Patient not able to understand and comply with study requirements, based onInvestigator's judgment.

  • Any other clinical condition that, based on Investigator's judgement, wouldjeopardize patient safety during trial participation or would affect the studyoutcome (e.g. immunocompromised patients, active malignancy, patients who might beat higher risk of developing genital or mycotic infections, patients with chronicviral infections, uncontrolled hypertension, cardiorenal and/or hepatorenalsyndrome, severe hepatic impairments etc.).

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Empagliflozin 25 MG
Phase: 3
Study Start date:
September 01, 2024
Estimated Completion Date:
December 01, 2025

Study 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.

Connect with a study center

  • Toronto General Hospital

    Toronto, Ontario M5G2N2
    Canada

    Active - Recruiting

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