EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)

NCT06531824
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
11,000
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Lead sponsor
Boehringer Ingelheim
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Start date
2024-08-30
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Number of sites
515
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Summary
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.
clinicaltrials.gov
Short title
EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)
clinicaltrials.gov
Official title
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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2028-08-30
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First posted
2024-08-01
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Registry last updated
2026-08-21
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Primary completion date
2028-08-30
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Start date
2024-08-30
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Participants
11,000
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Participant count basis
Estimated
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Planned participants
11,000
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Protocol amendments
6
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Number of sites
515
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Boehringer Ingelheim
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06531824
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ClinicalTrials.gov ID
NCT06531824
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Time to first occurrence of the primary composite outcome of: (i) Kidney disease progression*; or (ii) Hospitalization for heart failure; or (iii) Cardiovascular death.

    Timeframe: up to 4 years

    Kidney disease progression is defined as kidney failure or a sustained decline of ≥40% in estimated Glomerular Filtration Rate (eGFR) from randomization

  1. Key secondary outcome: Time to first event of kidney failure, hospitalization for heart failure or cardiovascular death

    Timeframe: up to 4 years

  2. Key secondary outcome: Time to first event of hospitalization for heart failure or cardiovascular death

    Timeframe: up to 4 years

  3. Key secondary outcome: Occurrences of hospitalizations from any cause (first and any subsequent, combined) or death from any cause

    Timeframe: up to 4 years

  4. Key secondary outcome: Time to death from any cause

    Timeframe: up to 4 years

  5. Key secondary outcome: Annual rate of change in eGFR from 1 month until last scheduled visit (i.e. chronic eGFR slope)

    Timeframe: up to 4 years

  6. Time to first event of kidney disease progression or cardiovascular death

    Timeframe: up to 4 years

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

Key Inclusion Criteria:

  • 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 visit, and requires:

    1. Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) eGFR ≥20 <45 mL/min/1.73m² (irrespective of diabetes status); or
    2. 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
    3. 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).

  • Neither requires an Aldosterone Synthase inhibitor (ASi) or Mineralocorticoid Receptor Antagonist (MRA), nor that such treatment is definitely inappropriate.

Key Exclusion Criteria:

  • Blood potassium of >5.2 mmol/L at screening visit
  • 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 criteria apply.
Sources for eligibility
clinicaltrials.gov

  • Apogee Clinical ResearchHuntsville, United StatesRecruiting
  • Southwest Kidney InstituteSurprise, United StatesRecruiting
  • National Heart InstituteBeverly Hills, United StatesRecruiting
  • University of Florida Health Shands HospitalGainesville, United StatesRecruiting
  • Florida Kidney Physicians LLCJacksonville Beach, United StatesRecruiting
  • Total Research Group, LLCMiami, United StatesRecruiting
  • Emory University School of MedicineAtlanta, United StatesRecruiting
  • Joseph Maxwell Cleland Atlanta VA Medical CenterDecatur, United StatesRecruiting
  • East Coast Institute For Research LLCMacon, United StatesRecruiting
  • Kootenai Research ServicesCoeur d'Alene, United StatesRecruiting
  • Northwestern UniversityChicago, United StatesRecruiting
  • University of Kansas Medical CenterKansas City, United StatesRecruiting
  • Kansas Nephrology Research Institute, LLCWichita, United StatesRecruiting
  • University of LouisvilleLouisville, United StatesRecruiting
  • Medstar Health Research InstituteBaltimore, United StatesRecruiting
  • Lake Michigan NephrologySaint Joseph, United StatesRecruiting
  • St. Clair Nephrology Research, LLCShelby, United StatesRecruiting
  • Minneapolis VA Health Care SystemMinneapolis, United StatesRecruiting
  • Southwest Mississippi Nephrology, PllcBrookhaven, United StatesRecruiting
  • Great Plains NephrologyNorth Platte, United StatesRecruiting
  • VA Southern Nevada Healthcare SystemNorth Las Vegas, United StatesRecruiting
  • Sierra Nevada Specialty CareReno, United StatesRecruiting
  • Seacoast Kidney and Hypertension SpecialistsPortsmouth, United StatesRecruiting
  • UNM Health Science CenterAlbuquerque, United StatesRecruiting
  • Metrolina Nephrology Associates, PACharlotte, United StatesRecruiting

And 490 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2024-511025-63-00
  • U1111-1306-5049
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)

Targets (1)