meChANisms and sAfety of SGLT2 Inhibition in peRitoneal dialYsis

NCT05715814 | Recruiting Phase 3

• 1 other identifier: 21-6198
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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; Kidney Dysfunction; Sodium-glucose Co-transporter-2 Inhibitors; Residual Kidney Function

Outcome Measures

Primary Outcomes (1)

• Change in measured GFR

  GFR will be determined from the average of creatinine and urea clearance from a 24-hour urine collection.

  Before and 2 weeks after initiation of empagliflozin.

Secondary Outcomes (17)

• Rebound in GFR after Cessation of Therapy

  2 weeks

• Change in ultrafiltration volume

  2 weeks

• Change in fraction of glucose remaining in the dialysate

  2 weeks

• Change in dialysate/plasma creatinine

  2 weeks

• Change in dialysate/plasma urea

  2 weeks

Study Arms (1)

Empagliflozin

EXPERIMENTAL

Drug: Empagliflozin 25 MG

Interventions

Empagliflozin 25 MG DRUG

PO once daily

Also known as: JARDIANCE

Empagliflozin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G2N2, Canada

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sunita KS Singh, MD MSc FRCPC

  University Health Network, Toronto General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vesta Lai

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 8, 2023
• Study Start: September 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

CA (1)