20 Participants Needed

Empagliflozin for Kidney Disease

(CANARY Trial)

VL
Overseen ByVesta Lai
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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.12345

Why 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?

SK

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

My peritoneal dialysis prescription hasn't changed recently.
My RAAS blocker dose has been the same for the last 30 days.
Signed and dated written informed consent.
See 1 more

Exclusion Criteria

I am scheduled for surgery or tests needing dye during the trial.
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.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 25mg of Empagliflozin daily to evaluate safety and efficacy in patients on peritoneal dialysis with residual kidney function

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a GFR measurement 2 weeks after cessation of therapy

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Empagliflozin
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: EmpagliflozinExperimental Treatment1 Intervention

Empagliflozin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Jardiance for:
🇺🇸
Approved in United States as Jardiance for:
🇨🇦
Approved in Canada as Jardiance for:
🇯🇵
Approved in Japan as Jardiance for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Published Research Related to This Trial

In the EMPA-KIDNEY trial involving 6609 patients with chronic kidney disease, empagliflozin significantly reduced the risk of kidney disease progression or death from cardiovascular causes compared to placebo, with a hazard ratio of 0.72, indicating a 28% lower risk.
Patients taking empagliflozin also experienced fewer hospitalizations for any cause compared to those on placebo, suggesting a potential safety benefit, although there were no significant differences in heart failure hospitalizations or overall mortality between the two groups.
Empagliflozin in Patients with Chronic Kidney Disease.Herrington, WG., Staplin, N., Wanner, C., et al.[2023]
In the EMPA-REG Outcome trial involving 6952 patients with type 2 diabetes and established cardiovascular disease, empagliflozin significantly reduced the risk of cardiovascular death by 38%, hospitalization for heart failure by 35%, and worsening kidney disease by 39% compared to placebo.
The efficacy of empagliflozin was consistent across different Kidney Disease Improving Global Outcomes (KDIGO) risk categories, indicating that its benefits on cardiovascular and kidney outcomes were not influenced by the patients' baseline chronic kidney disease status, although it was associated with a higher rate of genital infections.
Empagliflozin and Cardiovascular and Kidney Outcomes across KDIGO Risk Categories: Post Hoc Analysis of a Randomized, Double-Blind, Placebo-Controlled, Multinational Trial.Levin, A., Perkovic, V., Wheeler, DC., et al.[2023]
Empagliflozin (Jardiance) is now approved for reducing the risk of cardiovascular death and hospitalization in adults with heart failure, even in those without diabetes, highlighting its expanded therapeutic use.
Healthcare providers, including nurses and nurse practitioners, should closely monitor patients for potential adverse effects, particularly fluid deficits, to ensure patient safety during treatment.
Diabetes Drug Now Approved for Heart Failure.Aschenbrenner, DS.[2023]

Citations

Empagliflozin in Patients with Chronic Kidney DiseaseEmpagliflozin therapy led to a lower risk of progression of kidney disease or death from cardiovascular causes than placebo.
Effects of Empagliflozin on Progression of Chronic Kidney ...Empagliflozin slowed the rate of progression of CKD among all types of participant in the EMPA-KIDNEY trial, including those with little albuminuria.
Effects of empagliflozin on quality of life and healthcare use ...Probabilities of empagliflozin being cost-effective over 2 years were 43% and 61% and over 4 years were 91% and 94% at willingness to pay thresholds of £20,000 ...
Guidelines - Chronic Kidney Disease | Jardiance ClinicalAcute kidney injury requiring hospitalization and dialysis has been reported in patients with type 2 diabetes receiving SGLT2 inhibitors, including JARDIANCE.
Efficacy of Empagliflozin in Patients With Heart Failure ...Empagliflozin reduced the risk of cardiovascular death or hospitalizations for HF similarly in all Kidney Disease Improving Global Outcomes ( ...
Empagliflozin in Patients with Chronic Kidney Disease - PMCEmpagliflozin reduced the risk of the composite outcome of kidney disease ... Safety outcomes. Serious urinary tract infection, 52, (1.6%), 0.81 ...
Articles Impact of primary kidney disease on the effects ...The EMPA-KIDNEY trial showed that empagliflozin reduced the risk of the primary composite outcome of kidney disease progression or cardiovascular death in ...
Safety Profile for CKD | Jardiance® (empagliflozin) tabletsSee the JARDIANCE safety profile in the EMPA-KIDNEY trial for adult patients with chronic kidney disease. View Safety, PI and Med Guide.
Safety of Empagliflozin in Patients With Type 2 Diabetes and ...Use of empagliflozin in patients with type 2 diabetes and advanced CKD raised no new safety concerns and may have beneficial effects on the development of ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security