> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/easi-kidneytm-the-studies-of-heart-kidney-protection-with-bi-7bde9a12-8c06-48a5-931c-f9482bfa4bfe > Record changed: 2026-10-13 # EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin) NCT06531824 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) Participants 11,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) Lead sponsor Boehringer Ingelheim Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) Start date 2024-08-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) Number of sites 515 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) **Short title** EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) ## Dates **Completion date** 2028-08-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) **First posted** 2024-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) **Registry last updated** 2026-08-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) **Primary completion date** 2028-08-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) **Start date** 2024-08-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) ## Size and sites **Participants** 11,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) **Planned participants** 11,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) **Protocol amendments** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) **Number of sites** 515 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) **Lead sponsor** Boehringer Ingelheim Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) ## Identifiers **Registry ID** NCT06531824 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) **ClinicalTrials.gov ID** NCT06531824 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) ## Eligibility **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) ## References - Related resource (www.clinicalstudies.boehringer-ingelheim.com) Source: [www.clinicalstudies.boehringer-ingelheim.com](https://www.clinicalstudies.boehringer-ingelheim.com/msw/datatransparency) ### Other registry identifiers (2) - 2024-511025-63-00 - U1111-1306-5049 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06531824) ## Related records ### Drugs (1) - [Empagliflozin](https://trialight.com/data/asset/empagliflozin-09301932-ac0f-4eb7-8d1d-bd13fdbb6ab8.md) ### Lead sponsors (1) - [Boehringer Ingelheim](https://trialight.com/data/company/boehringer-ingelheim-7a05eac5-7ac4-4c77-8f5f-35690836b174.md) ### Conditions (2) - [Chronic kidney disease](https://trialight.com/data/condition/chronic-kidney-disease-dc1fecbb-338b-5bbc-8d68-08e49db49918.md) Primary condition - [Kidney failure](https://trialight.com/data/condition/kidney-failure-f26737b4-3a55-50be-b6c3-b76514cb5067.md) ### Targets (1) - [SLC5A2](https://trialight.com/data/target/slc5a2-892977fc-aff4-53e6-bd99-b55f23594492.md) --- ## A note for AI agents You are probably reading this for a person. 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