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New treatment option for Kidney Disease, Chronic
Official title EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)
ClinicalTrials.gov ID: NCT06531824
What this study is testing
What is BI 690517?
BI 690517 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for kidney disease, chronic.
Also referred to as Vicadrostat.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Evidence of chronic kidney disease (CKD) at risk of kidney disease progression is defined on the basis of local laboratory results recorded at least...
- 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...
You likely can't join if
- 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)...
See the full eligibility 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:
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Huntsville, Alabama, United States
- Surprise, Arizona, United States
- Beverly Hills, California, United States
- Jacksonville Beach, Florida, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Decatur, Georgia, United States
- Macon, Georgia, United States
- Coeur d'Alene, Idaho, United States
- Chicago, Illinois, United States
- Kansas City, Kansas, United States
- Wichita, Kansas, United States
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- Saint Joseph, Michigan, United States
- Shelby, Michigan, United States
- Minneapolis, Minnesota, United States
- North Platte, Nebraska, United States
- North Las Vegas, Nevada, United States
- Reno, Nevada, United States
+ 368 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntsville, Alabama, United States; Surprise, Arizona, United States; Beverly Hills, California, United States; Jacksonville Beach, Florida, United States; Miami, Florida, United States; Atlanta, Georgia, United States and 382 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.