EASi-KIDNEY: The study of heart and kidney protection with Vicadrostat in combination with Empagliflozin

Study Lead

Amanda Axler

University of Oxford (Academic lead), University of British Columbia (UBC – National lead)

Overview

Chronic kidney disease (CKD) is a common condition that can lead to kidney failure, heart failure, or early death. Although current treatments help, many people with CKD remain at high risk.

The EASi-KIDNEY study is testing whether adding a new medication called vicadrostat (BI 690517) to an established treatment called empagliflozin can better protect kidney and heart health.

About 11,000 people worldwide, including around 600 in Canada, are taking part. All participants receive empagliflozin, and half also receive vicadrostat while the other half receive a placebo (inactive pill). The study will follow participants for about 3–4 years with regular clinic visits and blood tests to monitor safety and kidney function.

The goal of this study is to find out whether this combination treatment can slow kidney disease progression, reduce hospitalizations for heart failure, and lower the risk of cardiovascular death.

Canadian study sites are located in:

Vancouver, Surrey, Prince George, Kelowna, Kamloops, Edmonton, Toronto, Kingston, London, Ottawa, Brampton, Concord, Oshawa, Québec City, Sherbrooke, Montréal, and Halifax.

Participant commitment:

  • Run-in period: 8-15 weeks on placebo tablets (empagliflozin provided).
  • Treatment phase: Randomization to daily vicadrostat 10mg or placebo, with empagliflozin continued.
  • In-person follow-up visits: at 1, 3, and 6 months, then every 6 months until enough trial events occur.
  • Assessments: blood and urine tests, medical history, interviews
  • Overall duration: 2-4 years

Additional information on website: easikidney.org

Eligibility

  • Must be 18 years or older
  • Established CKD at risk of progression, defined as:
    • eGFR ≥20 and <45 mL/min/1.73m², or
    • eGFR ≥45 and <90 mL/min/1.73m² with urine ACR ≥22.6 mg/mmol
  • Taking a clinically appropriate dose of a renin-angiotensin system (RAS) inhibitor (unless not tolerated or not indicated)
  • Able to start empagliflozin 10mg daily (or switch from another SGLT2 inhibitor)

Type of Participation

Clinical Trial

Diagnosis

Chronic Kidney Disease

Related Condition

Heart Disease, High Blood Pressure

Topic

Prevention, Quality of Life

Location

Alberta, British Columbia, Nova Scotia, Ontario, Quebec

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