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SGLT2 Inhibitor

Empagliflozin for Kidney Disease (CANARY Trial)

Phase 3
Waitlist Available
Led By Sunita KS Singh, MD MSc FRCPC
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Be older than 18 years old
Must not have
Planned surgery/procedures or radiologic investigations requiring contrast during the trial.
Type 1 diabetes.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will study how safe a type of diabetes drug is for people on dialysis with some kidney function.

Who is the study for?
Adults over 18 on peritoneal dialysis with some remaining kidney function, specifically at least 250 cc of daily urine output and a minimum GFR of 2 ml/min/1.73m^2. Participants must not have had recent organ transplants, be pregnant or nursing, have type 1 diabetes, recent heart or stroke events, drug abuse issues, or any condition that could affect safety or results as judged by the trial investigator.
What is being tested?
The study is testing the safety and how well Empagliflozin (25 MG), an SGLT2 inhibitor medication typically used for diabetes management, works in patients undergoing peritoneal dialysis who still retain some kidney function.
What are the potential side effects?
Potential side effects may include risks associated with SGLT2 inhibitors such as urinary tract infections, dehydration due to increased urination, low blood sugar levels if taking insulin or insulin-stimulating drugs concurrently; genital yeast infections; and possibly a rare occurrence of diabetic ketoacidosis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 or older, on peritoneal dialysis, and still produce a good amount of urine daily.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am scheduled for surgery or tests needing dye during the trial.
Select...
I have Type 1 diabetes.
Select...
I have had an organ transplant, including pancreas, pancreatic islet cells, or kidney.
Select...
I do not have blood disorders like anemia or conditions causing unstable red blood cells.
Select...
I am not pregnant, nursing, or planning to become pregnant during the trial.
Select...
I have had diabetic ketoacidosis in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in measured GFR
Secondary study objectives
Change in body composition (percent body mass, body fat, and muscle mass)
Change in degree of albuminuria
Change in eGFRβ2-microglobulin
+3 more

Side effects data

From 2024 Phase 4 trial • 72 Patients • NCT03193684
6%
Vaginal yeast infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment
Control

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: EmpagliflozinExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Empagliflozin 25 MG
2019
Completed Phase 4
~710

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,523 Previous Clinical Trials
503,322 Total Patients Enrolled
Sunita KS Singh, MD MSc FRCPCPrincipal InvestigatorUniversity Health Network, Toronto General Hospital
1 Previous Clinical Trials
52 Total Patients Enrolled

Media Library

Empagliflozin (SGLT2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05715814 — Phase 3
Peritoneal Dialysis Research Study Groups: Empagliflozin
Peritoneal Dialysis Clinical Trial 2023: Empagliflozin Highlights & Side Effects. Trial Name: NCT05715814 — Phase 3
Empagliflozin (SGLT2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05715814 — Phase 3
~10 spots leftby Jun 2025
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