EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)
Launched by BOEHRINGER INGELHEIM · Jul 29, 2024
Trial Information
Current as of June 07, 2025
Recruiting
Keywords
ClinConnect Summary
The EASi-KIDNEY™ trial is studying a new medicine called BI 690517 to see if it helps people with chronic kidney disease, especially when taken together with another medicine called empagliflozin. This study is open to adults who have chronic kidney disease and are at risk of it getting worse. You can participate whether or not you have type 2 diabetes, and you can still take other medicines that help protect your kidneys. To join, you need to have certain test results that show your kidney function is not normal but not too severe.
If you choose to participate, you will first take empagliflozin or a placebo (a pill that looks the same but has no medicine) for at least six weeks. Then, you will be randomly assigned to take either BI 690517 or another placebo daily, along with empagliflozin. Over the course of about three to four years, doctors will monitor your health through regular visits. They will check your kidney function, blood pressure, and overall health, looking for any signs that your kidney disease is worsening or if you experience heart problems. This trial is important because it aims to find ways to better protect kidney health and prevent serious complications.
Gender
ALL
Eligibility criteria
- 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; or
- • 2. CKD-EPI eGFR ≥45 \<90 mL/min/1.73m² with urine albumin-to-creatinine ratio (uACR) ≥200 mg/g (or protein-to-creatinine ratio ≥300 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
- • 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.
About Boehringer Ingelheim
Boehringer Ingelheim is a global, research-driven pharmaceutical company dedicated to improving health and quality of life through innovative therapies. Established in 1885 and headquartered in Ingelheim, Germany, the company focuses on the development of prescription medicines in key therapeutic areas, including respiratory diseases, cardiovascular health, oncology, and immunology. Boehringer Ingelheim is committed to advancing medical science through rigorous clinical trials and collaborative research, striving to bring novel treatments to patients while upholding the highest standards of safety and efficacy. With a strong emphasis on sustainability and corporate responsibility, the company aims to make a meaningful impact on global health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bristol, , United Kingdom
Hannover, , Germany
Genova, , Italy
Bologna, , Italy
Kuala Lumpur, , Malaysia
Melaka, , Malaysia
Gloucester, , United Kingdom
Bangalore, , India
Seoul, , Korea, Republic Of
Novara, , Italy
Chelmsford, , United Kingdom
Firenze, , Italy
Dortmund, , Germany
Pavia, , Italy
Taipei, , Taiwan
Elsenfeld, , Germany
London, , United Kingdom
Gießen, , Germany
Magdeburg, , Germany
Roma, , Italy
Aachen, , Germany
Kiel, , Germany
Frankfurt Am Main, , Germany
Kuantan, , Malaysia
Taiping, , Malaysia
Dorset, , United Kingdom
Kuching, , Malaysia
Winston Salem, North Carolina, United States
Pisa, , Italy
Oxford, , United Kingdom
Stuttgart, , Germany
Herlev, , Denmark
Kuala Lumpur, , Malaysia
Klang, , Malaysia
Parma, , Italy
Bad Oeynhausen, , Germany
Bonn, , Germany
Cuneo, , Italy
Frankfurt Am Main, , Germany
Bergamo, , Italy
Wonju Si, , Korea, Republic Of
Seremban, , Malaysia
Braunschweig, , Germany
Milano, , Italy
Kota Kinabalu, , Malaysia
Konstanz, , Germany
Busan, , Korea, Republic Of
Johor Bahru, , Malaysia
Batu Caves, , Malaysia
Lufkin, Texas, United States
Taipei, , Taiwan
Schweinfurt, , Germany
New Taipei City, , Taiwan
Villingen Schwenningen, , Germany
Patna, , India
Miami, Florida, United States
Portsmouth, New Hampshire, United States
Freiburg, , Germany
Neckarsulm, , Germany
Kajang, Selangor, , Malaysia
Muar, , Malaysia
Ipoh, , Malaysia
München, , Germany
Taiping, , Malaysia
Upland, Pennsylvania, United States
Frankfurt, , Germany
Pickering, , United Kingdom
Würzburg, , Germany
Vancouver, British Columbia, Canada
Rotenburg, , Germany
San Giovanni Rotondo (Foggia), , Italy
Kuala Pilah, , Malaysia
Serdang, , Malaysia
Temerloh, , Malaysia
Hyderabad, , India
Huntsville, Alabama, United States
Roskilde, , Denmark
Firenze, , Italy
Prato, , Italy
Verbania, , Italy
Batu Pahat, , Malaysia
Georgetown, , Malaysia
Kulim, , Malaysia
Perai, , Malaysia
Teluk Intan, , Malaysia
Belfast, , United Kingdom
Bury St Edmunds, , United Kingdom
Coeur D'alene, Idaho, United States
Shelby, Michigan, United States
Heilbronn, , Germany
København, , Denmark
East Providence, Rhode Island, United States
Roma, , Italy
Savona, , Italy
Surprise, Arizona, United States
Todi, , Italy
Hannover, , Germany
Saint Joseph, Michigan, United States
Pasadena, Texas, United States
Bad Nenndorf, , Germany
Chandigarh, , India
Raipur, , India
Parma, , Italy
Savona, , Italy
Clevedon, , United Kingdom
Berlin, , Germany
Wiesbaden, , Germany
Bangalore, , India
New Delhi, , India
Alessandria, , Italy
Asti, , Italy
Todi, , Italy
Kulim, , Malaysia
Brighton, , United Kingdom
Edmonton, Alberta, Canada
Hubballi, , India
Kozhikode, , India
New Delhi, , India
Cagliari, , Italy
Luodong Township, , Taiwan
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported