Actively Recruiting
A Multicenter, International, Randomized, Double-blind, Placebo-controlled Trial of BI 690517 Combined With Empagliflozin in Adults With Chronic Kidney Disease
Led by Boehringer Ingelheim · Updated on 2026-06-02
11000
Participants Needed
459
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of the medicine BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. This study includes people with or without type 2 diabetes and those who may or may not be taking certain blood pressure medicines such as ACE inhibitors or ARBs. The goal is to understand if adding BI 690517 to empagliflozin helps reduce the risk of kidney failure, heart disease, or hospitalization due to heart failure. The study has two parts. In the first part, all participants receive empagliflozin or a placebo similar to BI 690517 for at least six weeks while continuing any indicated ACEi or ARB treatments. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the remainder of the study. The study lasts about three to four years until enough events related to kidney or heart health occur. During the study, participants visit the study site about four times in the first six months and then every six months afterward. At these visits, doctors check health status, collect blood and urine samples, measure blood pressure and weight, assess kidney function, and monitor any side effects. Researchers track the time until worsening kidney disease, heart failure hospitalizations, or cardiovascular death to compare outcomes between treatment groups.
CONDITIONS
Brief Title
EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of chronic kidney disease at risk of progression based on kidney function and urine protein levels
- CKD-EPI eGFR between 20 and less than 45 mL/min/1.73m²; or eGFR between 45 and less than 90 mL/min/1.73m² with urine albumin-to-creatinine ratio of 200 mg/g or higher
- Stable treatment with angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB) if applicable
- Willingness to take empagliflozin and study medication as directed
You will not qualify if you...
- Blood potassium level greater than 5.2 mmol/L at screening
- Blood ALT or AST levels greater than three times the upper limit of normal at screening
- Known liver cirrhosis
- Currently on dialysis, have a functioning kidney transplant, or scheduled for living donor transplant
- Received new immunosuppression therapy for kidney disease within the last 60 days
- Receiving more than one renin-angiotensin system inhibitor (dual therapy with ACEi, ARB, or direct renin inhibitor)
- Currently taking mineralocorticoid receptor antagonists (e.g., spironolactone, eplerenone, finerenone)
- Currently treated with systemic mineralocorticoid replacement therapy (e.g., fludrocortisone)
- Other criteria may apply as determined by the study team
Research Team
B
Boehringer Ingelheim
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