EASi-KIDNEY™ Phase III trial for people with CKD

Unlike the beating of our hearts or the sound of our gut letting us know we are hungry, our kidneys work quietly in the background filtering our blood and keeping the composition of our body fluids balanced. But when chronic kidney disease (CKD) strikes, these silent heroes falter. Too often, CKD symptoms go unnoticed or undetected until later stages of the disease. By then, CKD becomes harder to treat and may have already caused or worsened other connected conditions, including heart failure. Sandy Sommer, Head of the Therapeutic Area for Cardiovascular, Renal and Metabolic at Boehringer Ingelheim, explains why the EASi-KIDNEY™ Phase III clinical trial could be a game-changer for people living with CKD and interconnected conditions worldwide.

The real-world impact of CKD and its connection with cardiovascular, renal and metabolic conditions

It’s no secret that CKD has a huge impact worldwide. This disease – caused by progressive kidney damage – affects over 850 million people globally, which is more than 10% of the world's population. The most shocking part? In some parts of the world, up to 90% of these people may be unaware they have it.

There’s a reason why CKD is often called a ‘silent killer’. CKD often develops without noticeable symptoms in its early stages, leading to delayed diagnosis. For those living with other cardiovascular, renal and metabolic conditions, including high blood pressure and type 2 diabetes, routine testing for CKD is crucial. Detecting CKD early can slow disease progression and reduce the likelihood of serious health complications, including heart diseases, so it is important these risk factors are tested early with two simple urine and blood tests. Delayed diagnosis also places a heavy burden on individuals, families, and healthcare systems, leading to increased hospitalizations and more complex treatments required in later stages. All the more important is early detection to change the course of CKD.

"There is a wide overlap between CKD and connected cardiovascular, renal and metabolic conditions, including chronic heart failure, obesity and diabetes. In fact, many people living with progressive CKD are more likely to die prematurely from cardiovascular disease and related complications than to reach kidney failure. Delayed CKD diagnosis can impact more than just kidney health, so the sooner the condition is diagnosed, the better we can manage it, and we’re excited that the EASi-KIDNEY trial is one of the largest ever conducted in this population.” – Dr Waheed Jamal, M.D., Corporate Vice President and Head of Cardiovascular Renal Metabolic Medicine at Boehringer Ingelheim

Transforming care with the EASi-KIDNEY™ Phase III trial

The initiation of the international EASi-KIDNEY™ Phase III trial program marks a crucial stride forward in our goal to provide new solutions for people living with CKD and connected conditions. Developed in collaboration with Oxford Population Health and other expert scientists around the globe, the trials will investigate the efficacy and safety profile of vicadrostat, previously known as BI 690517, given in combination with empagliflozin, compared to placebo and empagliflozin on top of standard of care, in around 11,000 people with established kidney disease.

Vicadrostat is an investigational drug, which has not been approved for any proposed indication by any regulatory authority including the U.S. Food and Drug Administration. Boehringer Ingelheim is currently investigating its efficacy and safety profile. Empagliflozin is an SGLT2-inhibitor that has demonstrated efficacy in patients with CKD in the landmark EMPA-KIDNEY™Phase III trial. By potentially mitigating the risk of hyperkalemia (elevated potassium levels), empagliflozin may play a crucial role in ensuring this potential treatment is well-tolerated by a wider patient population.

Importantly, the EASi-KIDNEY™ Phase III trial program goes beyond improving kidney disease: it will provide valuable insights into whether the combination of these two treatments is more effective than empagliflozin alone while potentially reducing the risk of kidney disease progression, cardiovascular death or hospitalization due to heart failure.

The potential of vicadrostat for a holistic approach to care

We have high hopes for vicadrostat, a selective aldosterone synthase inhibitor (ASi), that works by reducing aldosterone production. Excessive levels of aldosterone can cause organ damage and worsen cardiovascular, renal and metabolic conditions including CKD, heart failure, and hypertension. This means that when combined with empagliflozin, vicadrostat may offer more than just kidney protection — it has potential to improve other aspects of health.

“Earlier this year, we were delighted to announce the initiation of our EASi-HF Phase III trial for people living with chronic heart failure with preserved ejection fraction (HFpEF). Together with EASi-KIDNEY™, these clinical trial programs will generate a large body of evidence on how vicadrostat in combination with empagliflozin may protect the kidneys and heart. If innovative treatments can be offered to people with CKD or heart failure, we may help reduce disease progression or further complications.” – Prof Dr Sibylle Hauske, M.D., Evidence Lead, Cardiovascular Renal Metabolic Medicine at Boehringer Ingelheim

The combined use of vicadrostat with empagliflozin has already shown promising results in a Phase II trial in chronic kidney disease in 2023, with full data results demonstrating a significant reduction of excessive levels of protein in the urine (albuminuria) by up to 39.5% vs placebo.

The combination of vicadrostat and empagliflozin could offer new hope for people living with CKD. By addressing both kidney and heart health, vicadrostat together with empagliflozin has the potential to improve how we treat these interconnected conditions, with the goal of giving people more time to spend with their families, more time to enjoy a healthy life, and more time to live life to the fullest.

Our vision for the future is clear: to provide new, innovative solutions that address not only CKD but all interconnected conditions, enabling a healthier future for all.