Testing BI 690517 against a placebo for chronic kidney disease
Official title: EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)
A Multicenter, International, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Aldosterone Synthase Inhibitor BI 690517 in Combination With Empagliflozin in Patients With Chronic Kidney Disease
- Phase 3
- 3 groups
- Sites in Montreal, Québec and 15 more cities
- Recruiting
Interventions
- Medication
BI 690517
BI 690517 (called Type M randomized treatment)
- Medication
Placebo matching BI 690517
Placebo matching BI 690517
- Medication
Empagliflozin
Empagliflozin (called Type E)
Canadian Sites (24)
24 of 24 recruiting
- Recruiting
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta
- Recruiting
Royal Inland Hospital
Kamloops, British Columbia
- Recruiting
Kelowna General Hospital
Kelowna, British Columbia
- Recruiting
Northern Health
Prince George, British Columbia
- Recruiting
Fraser Health
Surrey, British Columbia
- Recruiting
St. Paul's Hospital (Vancouver)
Vancouver, British Columbia
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia
- Recruiting
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal
- Recruiting
CIUSSS Nord de l'île de Montreal
Québec, Montréal
- Recruiting
Centre for Clinical Research
Halifax, Nova Scotia
- Recruiting
Centricity Research (Brampton)
Brampton, Ontario
- Recruiting
Centricity Research (Vaughan)
Concord, Ontario
- Recruiting
Queen's University
Kingston, Ontario
- Recruiting
London Regional Cancer Program - London Health Sciences Ctr.
London, Ontario
- Recruiting
Lakeridge Health Oshawa
Oshawa, Ontario
- Recruiting
The Ottawa Hospital
Ottawa, Ontario
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario
- Recruiting
St. Michael's Hospital
Toronto, Ontario
- Recruiting
Toronto General Hospital
Toronto, Ontario
- Recruiting
CHU de Quebec-Universite Laval Research Centre
Québec
- Recruiting
Diex Recherche Québec
Québec
- Recruiting
CIUSSS de l'Est-de-l'Île-de-Montréal
Montreal, Quebec
- Recruiting
McGill University Health Centre (MUHC)
Montreal, Quebec
- Recruiting
CIUSSS de l Estrie-CHUS
Sherbrooke, Quebec
Eligibility Criteria
See who this study is looking for13 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) eGFR ≥20 \<45 mL/min/1.73m² (irrespective of diabetes status); or
- +No self-reported diabetes: CKD-EPI eGFR ≥45 \<90 mL/min/1.73m² with urine albumin-to-creatinine ratio (uACR) ≥150 mg/g (or protein-to-creatinine ratio ≥225 mg/g); or
- +Self-reported diabetes: CKD-EPI eGFR ≥45 \<90 mL/min/1.73m² with uACR ≥30 mg/g (or protein-to-creatinine ratio ≥45 mg/g).
- +Evidence of chronic kidney disease (CKD) at risk of kidney disease progression is defined on the basis of local laboratory results recorded at least 3 months before and at the time of the Screening visitScreeningThe checks done before joining, to see whether a study fits.Read more →, and requires:
- +Neither requires an Aldosterone Synthase inhibitor (ASi) or Mineralocorticoid Receptor Antagonist (MRA), nor that such treatment is definitely inappropriate.
Exclusion
- −Blood potassium of \>5.2 mmol/L at screening visitScreeningThe checks done before joining, to see whether a study fits.Read more →
- −Blood Alanine Transaminase (ALT) or Aspartate Transaminase (AST) \>3x Upper Limit of Normal (ULN) at Screening visit (only one is required, with ALT preferred)
- −Known liver cirrhosis
- −On dialysis, functioning kidney transplant, or scheduled living donor transplant
- −Treated with new immunosuppression therapy for new (or relapse/flare of pre-existing) kidney disease within the last 60 days
- −Receiving more than one Renin-Angiotensin System (RAS) inhibitor (i.e. on dual therapy with two of an Angiotensin-Converting Enzyme inhibitor (ACEi), Angiotensin Receptor Blocker (ARB) or direct renin inhibitor)
- −Currently treated with an Mineralocorticoid Receptor Antagonist (MRA) (e.g. spironolactone, eplerenone, finerenone)
- −Currently treated with systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) Further exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → apply.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Group A receives Empagliflozin.
Registry label: A: Part 1: Run-in period (all participants)
Group B receives one or more of: BI 690517 and Empagliflozin.
Registry label: B: Part 2: Randomized treatment, follow-up period, treatment group
Group C, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives one or more of: Placebo matching BI 690517 and Empagliflozin.
Registry label: C: Part 2: Follow-up period, placebo group
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 11,000 people.
The study is currently expected to finish around August 2028.
The main measurement is taken over: up to 4 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Time to first occurrence of the primary composite outcome of: (i) Kidney disease progression*; or (ii) Hospitalization for heart failure; or (iii) Cardiovascular death — measured over up to 4 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06531824 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About BI 690517Drug
BI 690517 (called Type M randomized treatment)
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Placebo matching BI 690517Drug
Placebo matching BI 690517
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About EmpagliflozinDrug
Empagliflozin (called Type E)
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: up to 4 years.
The study as a whole is currently expected to finish around 2028-08-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 11,000 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 23 locations, including: Montreal, Canada; Québec, Canada; Edmonton, Alberta, Canada; Kamloops, British Columbia, Canada; Kelowna, British Columbia, Canada; Prince George, British Columbia, Canada, and 17 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This study is open to adults with chronic kidney disease at risk of progression. People with and without type 2 diabetes can take part in this study. The study is open to people who take other medicines called angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB). People who already take empagliflozin or any other sodium-glucose cotransporter-2 inhibitor (SGLT2i) can also join. The study is also open to people who currently do not take any of these treatments. The purpose of this study is to find out whether a medicine called BI 690517 helps people with chronic kidney disease when taken in combination with a study medicine called empagliflozin. Worsening of kidney function increases the risk for kidney failure, cardiovascular disease, and heart failure hospitalisation. After a run-in period, during which participants are confirmed to be receiving clinically appropriate renin-angiotensin system blockade and are established on empagliflozin, they are randomly assigned (by chance) to 1 of 2 groups. One group receives BI 690517 tablets, and the other group receives placebo tablets. Placebo tablets look like BI 690517 but do not contain any medicine. Participants take 1 study tablet once a day, in addition to empagliflozin, for the duration of the study. The doctors document when participants experience worsening of their kidney disease, go to hospital due to heart failure, or die of cardiovascular problems during the study. The time to these events is compared between the 2 treatment groups to see whether the treatment works. The study continues until the required number of events have occurred which is about 3 to 4 years. During this time, participants visit the study site about 5 times within the first 6 months. Then they visit the study site every 6 months. At the visits, doctors regularly check participants' health, take blood and urine samples, measure blood pressure and weight, check kidney function, and take note of any unwanted effects.
Other Sites (4)
Lake Michigan Nephrology
Saint Joseph, Michigan, United States
St. Clair Nephrology Research, LLC
Shelby, Michigan, United States
Minneapolis VA Health Care System
Minneapolis, Minnesota, United States
Providence Medical Research Center
Spokane, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.