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Search / Trial NCT06531824

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.

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

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported