Status:
RECRUITING
EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Kidney Disease, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 medicin...
Eligibility Criteria
Inclusion
- Key
- 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:
- Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) eGFR ≥20 \<45 mL/min/1.73m²; or
- 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
- 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.
Key Trial Info
Start Date :
August 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2028
Estimated Enrollment :
11000 Patients enrolled
Trial Details
Trial ID
NCT06531824
Start Date
August 13 2024
End Date
August 30 2028
Last Update
December 22 2025
Active Locations (329)
Enter a location and click search to find clinical trials sorted by distance.
1
Apogee Clinical Research
Huntsville, Alabama, United States, 35805-4104
2
Southwest Kidney Institute
Surprise, Arizona, United States, 85374-4840
3
Florida Kidney Physicians LLC
Jacksonville Beach, Florida, United States, 32250-4303
4
Total Research Group, LLC
Miami, Florida, United States, 33126