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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
CANARY Trial 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.Check my eligibility
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.See study design
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.
CANARY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older, on peritoneal dialysis, and still produce a good amount of urine daily.
CANARY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in measured GFR
Secondary outcome measures
Change in BNP (NT-proB-type Natriuretic Peptide)
Change in body composition (percent body mass, body fat, and muscle mass)
Change in body weight
+14 moreSide effects data
From 2023 Phase 1 & 2 trial • 29 Patients • NCT0490721417%
Skin infection
17%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Empagliflozin
CANARY 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
2018
Completed Phase 4
~390
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,499 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for surgery or tests needing dye during the trial.My peritoneal dialysis prescription hasn't changed recently.I have Type 1 diabetes.You have had problems with alcohol or drugs in the past 3 months that could affect your ability to take part in the trial, as decided by the doctor.I have had an organ transplant, including pancreas, pancreatic islet cells, or kidney.You have any medical condition that the doctor thinks could make it unsafe for you to be in the study or could affect the study results.My RAAS blocker dose has been the same for the last 30 days.I have not taken SGLT2 inhibitors in the last 30 days.I have not had peritoneal dialysis-related peritonitis in the last 30 days.I have had a heart attack or stroke in the last 30 days.I do not have blood disorders like anemia or conditions causing unstable red blood cells.I understand and can follow the study's requirements.I am not pregnant, nursing, or planning to become pregnant during the trial.I have had diabetic ketoacidosis in the past.I am 18 or older, on peritoneal dialysis, and still produce a good amount of urine daily.
Research Study Groups:
This trial has the following groups:- Group 1: Empagliflozin
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Empagliflozin sanctioned by the FDA?
"With a score of 3, our team at Power assesses that Empagliflozin is safe for use due to prior clinical data confirming its efficacy and safety."
Answered by AI
Are enrollees currently being sought for this clinical trial?
"The clinicaltrials.gov database reveals that this medical trial, which was initially posted on April 1st 2023 and last modified January 27th 2023 is not presently seeking participants. Nonetheless, there are 585 other studies searching for patients at the moment."
Answered by AI
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