Empagliflozin for Kidney Disease
(CANARY Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a drug called empagliflozin to evaluate its safety and effectiveness for people with kidney disease who are on peritoneal dialysis but still retain some kidney function. The focus is on understanding the drug's impact on kidney function and overall health. Suitable participants have been on stable peritoneal dialysis and produce at least 250 cc of urine daily. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications, but you must have a stable dose of RAAS blockade if you are on this type of medication. You also cannot have used an SGLT2 inhibitor in the 30 days before the trial.
Is there any evidence suggesting that Empagliflozin is likely to be safe for humans?
Previous studies have shown that empagliflozin is safe for people with chronic kidney disease. Research indicates that empagliflozin can lower the risk of worsening kidney problems and reduce the chance of dying from heart-related issues. Serious side effects, such as urinary tract infections, were rare, occurring in only 1.6% of patients.
For those with type 2 diabetes and advanced chronic kidney disease, empagliflozin did not present new safety concerns and might even support kidney health. As this trial is in a later stage, earlier studies have likely addressed any major safety issues, providing some confidence about its safety in humans.12345Why do researchers think this study treatment might be promising?
Most treatments for kidney disease focus on managing symptoms and slowing progression, usually involving blood pressure medications or dialysis. But empagliflozin works differently, targeting sodium-glucose co-transporter 2 (SGLT2) in the kidneys. This mechanism not only helps control blood sugar levels but also reduces the risk of kidney damage by decreasing pressure in the kidney's filtering units. Researchers are excited about empagliflozin because it has shown promise in protecting kidney function, offering a potential dual benefit for patients with kidney disease, especially those with diabetes.
What evidence suggests that Empagliflozin might be an effective treatment for kidney disease?
Research has shown that empagliflozin, which participants in this trial will receive, can help slow chronic kidney disease (CKD). One study found that it reduced the risk of disease progression or death from heart problems. Another study demonstrated that empagliflozin slowed CKD progression, even in individuals with only a small amount of protein in their urine. These findings suggest that empagliflozin might benefit people with kidney issues.16789
Who Is on the Research Team?
Sunita KS Singh, MD MSc FRCPC
Principal Investigator
University Health Network, Toronto General Hospital
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 25mg of Empagliflozin daily to evaluate safety and efficacy in patients on peritoneal dialysis with residual kidney function
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a GFR measurement 2 weeks after cessation of therapy
What Are the Treatments Tested in This Trial?
Interventions
- Empagliflozin
Empagliflozin is already approved in European Union, United States, Canada, Japan for the following indications:
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
- Cardiovascular risk reduction
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor