A Multicenter, International, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Aldosterone Synthase Inhibitor BI 690517 in Combination With Empagliflozin in Patients With Chronic Kidney Disease

Plain English Summary

EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin) is a Phase 3 clinical trial sponsored by Boehringer Ingelheim studying Kidney Disease, Chronic. Tests a new medicine (BI 690517) in combination with empagliflozin to slow kidney disease progression. For adults with chronic kidney disease at risk of worsening, regardless of diabetes status. Participation involves taking study medication daily and regular visits to the study site for health checks. Alternatives include standard treatments like ACEi or ARB, but this study aims to find a new effective treatment. The trial aims to enroll 11000 participants.

Official 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 medicines called angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB). People who already take empagliflozin or any other sodium-glucose cotransporter-2 inhibitor (SGLT2i) can also join. The study is also open to people who currently do not take any of these treatments. The purpose of this study is to find out whether a medicine called BI 690517 helps people with chronic kidney disease when taken in combination with a study medicine called empagliflozin. Worsening of kidney function increases the risk for kidney failure, cardiovascular disease, and heart disease. This study has 2 parts. In the first part, participants get empagliflozin or placebo matching BI 690517 for at least 6 weeks. Participants continue taking ACEi or ARB throughout the study if such treatments are indicated. In the second part, participants are divided into 2 groups by chance. One group takes BI 690517 tablets and the other group takes placebo tablets. Placebo tablets look like BI 690517 tablets but do not contain any medicine. Participants take 1 tablet once a day in addition to empagliflozin for the duration of the study. The doctors document when participants experience worsening of their kidney disease, go to hospital due to heart failure, or die of cardiovascular problems during the study. The time to these events is compared between the 2 treatment groups to see whether the treatment works. The study continues until the required number of events have occurred which is about 3 to 4 years. During this time, participants visit the study site about 4 times within the first 6 months. Then they visit the study site every 6 months. At the visits, doctors regularly check participants' health, take blood and urine samples, measure blood pressure and weight, check kidney f

Who Can Participate

Here is what you need to know about eligibility for this trial. Eligible if you have chronic kidney disease with an eGFR of 20-90 mL/min/1.73m² and a uACR ≥200 mg/g. Not eligible if you have high potassium levels, liver cirrhosis, or are on dialysis. Age range: 18 years and older. Health requirements: Must be stable on ACEi or ARB. This trial is studying Kidney Disease, Chronic, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures the time to first occurrence of kidney disease progression, hospitalization for heart failure, or cardiovascular death, which is crucial for patients to understand their r The specific primary outcome measures are: Time to first occurrence of the primary composite outcome of: (i) Kidney disease progression*; or (ii) Hospitalization for heart failure; or (iii) Cardiovascular death. (up to 4 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses a critical gap in treatment for chronic kidney disease, potentially offering a new way to slow disease progression. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Kidney Disease, Chronic, where improved treatment options are needed.

Investor Insight

Market size is significant, with chronic kidney disease affecting millions globally. This study could fill a critical treatment gap, making it an attractive investment opportunity. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 11000 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if you have chronic kidney disease and are at risk of progression. Participation involves taking daily study medication and regular health checks at the study site. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 11,000 participants

Interventions

• DRUG: BI 690517 — BI 690517
• DRUG: Placebo matching BI 690517 — Placebo matching BI 690517
• DRUG: Empagliflozin — Empagliflozin

Primary Outcomes

• Time to first occurrence of the primary composite outcome of: (i) Kidney disease progression*; or (ii) Hospitalization for heart failure; or (iii) Cardiovascular death. (up to 4 years)

Secondary Outcomes

• Key secondary outcome: Annual rate of change in eGFR from 3 month visit until last scheduled visit (i.e. chronic eGFR slope) (up to 4 years)
• Time to first event of kidney failure, hospitalization for heart failure or cardiovascular death (up to 4 years)
• Time to kidney disease progression (up to 4 years)
• Occurrences of hospitalizations for heart failure (first and any subsequent, combined) or cardiovascular death (up to 4 years)
• Occurrences of hospitalizations from any cause (first and any subsequent, combined) (up to 4 years)

Full 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.

Trial Locations

• Apogee Clinical Research, Huntsville, Alabama, United States
• Southwest Kidney Institute, Surprise, Arizona, United States
• Florida Kidney Physicians LLC, Jacksonville Beach, Florida, United States
• Total Research Group, LLC, Miami, Florida, United States
• East Coast Institute For Research LLC, Macon, Georgia, United States
• Kootenai Research Services, Coeur d'Alene, Idaho, United States
• Northwestern University, Chicago, Illinois, United States
• University of Kansas Medical Center, Kansas City, Kansas, United States
• Kansas Nephrology Research Institute, LLC, Wichita, Kansas, United States
• Medstar Health Research Institute, Baltimore, Maryland, United States
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Chronic Kidney Disease
• Heart Failure
• Cardiovascular Disease
• Diabetes
• Hypertension
• Renal Transplant
• Nephrotic Syndrome
• Polycystic Kidney Disease
• Glomerulonephritis
• Renal Artery Stenosis

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