Empagliflozin for Kidney Disease
(CANARY Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: University Health Network, Toronto
Must not be taking: SGLT2 inhibitors
Disqualifiers: Type 1 diabetes, Organ transplant, Pregnancy, Alcohol or drug abuse, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?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).
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.
What data supports the effectiveness of the drug empagliflozin for kidney disease?
Empagliflozin has been shown to reduce the progression of chronic kidney disease and lower the risk of cardiovascular issues in patients with type 2 diabetes and established cardiovascular disease. In the EMPA-REG Outcome trial, it significantly reduced the risk of cardiovascular death, hospitalization for heart failure, and worsening kidney problems.
12345Is empagliflozin safe for people with kidney disease?
Empagliflozin (Jardiance) is generally considered safe for people, including those with chronic kidney disease (CKD), but it can have side effects like fluid deficits. It has been studied in various conditions, showing benefits for heart and kidney health, but patients should be monitored for any adverse effects.
56789How does the drug empagliflozin differ from other treatments for kidney disease?
Empagliflozin is unique because it is a sodium-glucose co-transporter-2 (SGLT2) inhibitor that not only helps manage blood sugar levels in type 2 diabetes but also offers kidney and heart protection, reducing the progression of chronic kidney disease and cardiovascular risks. Unlike some other treatments, it works independently of insulin and can lower blood pressure and body weight, making it a multifaceted option for patients with kidney disease.
245710Eligibility Criteria
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.
+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.
+11 more
Trial Timeline
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
Participant Groups
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.
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:
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
🇺🇸 Approved in United States as Jardiance for:
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
- Cardiovascular risk reduction
🇨🇦 Approved in Canada as Jardiance for:
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
🇯🇵 Approved in Japan as Jardiance for:
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Toronto General HospitalToronto, Canada
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Who Is Running the Clinical Trial?
University Health Network, TorontoLead Sponsor
References
Empagliflozin in Patients with Chronic Kidney Disease. [2023]The effects of empagliflozin in patients with chronic kidney disease who are at risk for disease progression are not well understood. The EMPA-KIDNEY trial was designed to assess the effects of treatment with empagliflozin in a broad range of such patients.
Effects of empagliflozin on progression of chronic kidney disease: a prespecified secondary analysis from the empa-kidney trial. [2023]Sodium-glucose co-transporter-2 (SGLT2) inhibitors reduce progression of chronic kidney disease and the risk of cardiovascular morbidity and mortality in a wide range of patients. However, their effects on kidney disease progression in some patients with chronic kidney disease are unclear because few clinical kidney outcomes occurred among such patients in the completed trials. In particular, some guidelines stratify their level of recommendation about who should be treated with SGLT2 inhibitors based on diabetes status and albuminuria. We aimed to assess the effects of empagliflozin on progression of chronic kidney disease both overall and among specific types of participants in the EMPA-KIDNEY trial.
Empagliflozin and Cardiovascular and Kidney Outcomes across KDIGO Risk Categories: Post Hoc Analysis of a Randomized, Double-Blind, Placebo-Controlled, Multinational Trial. [2023]In the Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG Outcome), empagliflozin, in addition to standard of care, significantly reduced risk of cardiovascular death by 38%, hospitalization for heart failure by 35%, and incident or worsening nephropathy by 39% compared with placebo in patients with type 2 diabetes and established cardiovascular disease. Using EMPA-REG Outcome data, we assessed whether the Kidney Disease Improving Global Outcomes (KDIGO) CKD classification had an influence on the treatment effect of empagliflozin.
In CKD, once-daily empagliflozin reduced progression of kidney disease or CV death at 2 y. [2023]Label="SOURCE CITATION">EMPA-KIDNEY Collaborative Group; Herrington WG, Staplin N, Wanner C, et al. Empagliflozin in patients with chronic kidney disease. N Engl J Med. 2023;388:117-27. 36331190.
The dual role of empagliflozin: Cardio renal protection in T2DM patients. [2022]Empagliflozin (Jardiance®) is an insulin independent antihyperglycemic agent used in treatment of T2D.The drug is a sodium glucose cotransporter-2 (SGLT2) inhibitor approved in USA and Europe and other countries of the world. As empagliflozin demonstrates cardioprotective and Reno protective properties its prime target are patients having CVD and CKD complicated by T2D. This review sheds light on mechanism of action of the drug and with the help of clinical outcomes establishes the use of empagliflozin in T2D patients. Although empagliflozin is a well-tolerated and easy to administer drug, it has some side effects and contraindications which are discussed in the article to help the reader weigh its beneficial effects against its adverse effect and understand its use in clinical medicine.
Diabetes Drug Now Approved for Heart Failure. [2023]The diabetes drug empagliflozin (Jardiance) is now approved to reduce the risk of cardiovascular death and hospitalization in adults with heart failure, even if they do not have diabetes.Nurses and NPs should monitor patients for adverse effects, especially fluid deficits.
Design, recruitment, and baseline characteristics of the EMPA-KIDNEY trial. [2023]The effects of the sodium-glucose co-transporter 2 inhibitor empagliflozin on renal and cardiovascular disease have not been tested in a dedicated population of people with chronic kidney disease (CKD).
Comparative Safety Analysis of Empagliflozin in Type 2 Diabetes Mellitus Patients with Chronic Kidney Disease versus Normal Kidney Function: A Nationwide Cohort Study in Korea. [2023]Empagliflozin has been shown to reduce cardiovascular morbidity and mortality in patients with type 2 diabetes. Various research on its efficacy in patients with chronic kidney disease (CKD) have been actively conducted. So far, few studies have investigated the safety of these adverse effects specifically in Asians with CKD. We aim to address these safety concerns on a patient population of Asian CKD patients using real-world data.
Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. [2022]To assess the safety of empagliflozin in patients with type 2 diabetes and moderate to severe chronic kidney disease (CKD) (category G3-4) enrolled in clinical trials.
[EMPAGLIFLOZIN (JARDIANCE) :Nw SGLT2 COTRANSPORTER INHIBITOR FOR TREATING TYPE 2 DIABETES]. [2022]Empagliflozin is a new inhibitor of sodiumglucose cotransporters type 2 (SGLT2) for the treatment of type 2 diabetes mellitus (T2DM). Its specific action inhibits glucose reabsorption in renal tubules and thus promotes glucosuria. This effect results in a reduction in fasting and postprandial glycaemia and a decrease of glycated haemoglobin (HbA(Ic)), independently of insulin. Furthermore, calorie urinary loss promotes weight reduction and osmotic diuresis lowers arterial blood pressure. The efficacy of empagliflozin increases according to the level of hyperglycaemia but decreases in patients with renal insufficiency. In 24 to 104-week controlled trials versus placebo, empagliflozin reduces HbA(1c) (approximately 0.8%), without hypoglycaemia (except in patients already treated with insulin or sulphonylureas). This improvement in glucose control is rather similar to that observed with active comparators (metformin, glimepiride or sitagliptin), with the advantage for empagliflozin of reducing body weight (approximately 2 kg) and blood pressure (systolic approximately 4 mm Hg and diastolic approximately 2 mm Hg). Empagliflozin has shown a cardiovascular protection in the EMPA-REG OUTCOME trial. Mycotic genital infections occur more frequently, especially in women, while a negligible increase in mild urinary tract infections may be observed. The risk of hypotension and volume depletion is low, although it should be carefully checked in more fragile and at risk patients. Empagliflozin (Jardiance), which is commercialized at the doses of 10 mg and 25 mg once daily, is indicated for the treatment of T2DM and reimbursed in Belgium with conditions as add-on to a background glucose-lowering therapy.