Boehringer Ingelheim has discontinued the Phase 3 EASi-KIDNEY trial of vicadrostat in chronic kidney disease after DMC review found no meaningful expected clinical benefit.
Written By: Saniya Katakdhond, PharmD
Reviewed By: Pharmacally Editorial Team
Boehringer Ingelheim has discontinued the Phase III EASi-KIDNEY trial (NCT06531824) after an independent Data Monitoring Committee (DMC) review found that accumulating data did not support a meaningful expectation of clinical benefit for the primary composite endpoint in people with chronic kidney disease (CKD).
DMC Recommends Discontinuation
EASi-KIDNEY, conducted in partnership with the University of Oxford, evaluated investigational vicadrostat (BI 690517) in combination with empagliflozin versus empagliflozin alone.
The study was investigating whether adding vicadrostat could slow kidney disease progression and reduce cardiovascular risk in people with CKD. Following a comprehensive assessment of the available benefit-risk data, Boehringer Ingelheim concluded that continuing the trial was unlikely to provide meaningful clinical benefit for the study population.
The company did not identify a new safety signal as the stated reason for discontinuation. Instead, the decision was driven by the accumulating efficacy data and the resulting assessment of the expected clinical benefit.
Vicadrostat Blocks Aldosterone Production
Vicadrostat is an investigational aldosterone synthase inhibitor that reduces the production of aldosterone, a hormone involved in sodium retention, blood pressure regulation and cardiovascular and renal injury.
Aldosterone signaling has therefore become an area of interest in cardiorenal disease, particularly in patients in whom kidney dysfunction and cardiovascular risk frequently coexist.
EASi-KIDNEY evaluated whether targeting this pathway with vicadrostat could provide additional protection when added to empagliflozin, an SGLT2 inhibitor with an established role across several cardiovascular and kidney disease settings.
Primary Endpoint Focused on Kidney and Cardiovascular Outcomes
The trial’s primary composite endpoint was intended to capture clinically meaningful progression of kidney disease and cardiovascular outcomes. This approach reflects the interconnected nature of CKD, in which declining renal function and cardiovascular events contribute substantially to morbidity and mortality.
However, the accumulating data did not support a meaningful expectation that vicadrostat plus empagliflozin would deliver the required benefit on the primary composite endpoint compared with empagliflozin alone.
The company has not released detailed efficacy results, component-level event rates, hazard ratios or statistical analyses from EASi-KIDNEY. Further analyses are ongoing.
Three Other Phase III Studies Continue
The discontinuation applies specifically to EASi-KIDNEY and does not extend to the remainder of the EASi program.
The program includes three ongoing Phase III studies: EASi-HF Preserved, EASi-HF-Reduced and EASi-PROTKT. Following separate reviews of currently available data from these trials, their respective DMCs recommended that they continue unchanged.
This means the EASi-KIDNEY decision should not be interpreted as a program-wide termination of vicadrostat development. The other studies are being evaluated independently in their respective patient populations and clinical settings.
Participants Being Contacted
Health authorities, investigators and study sites are being informed of the decision. Investigators are contacting participants and providing guidance on study treatment and trial closure.
Vicadrostat remains investigational and has not received marketing authorization in any country. The EASi-KIDNEY outcome does not change the approved use or established benefit-risk profile of empagliflozin, which has been marketed since 2014.
Boehringer Ingelheim Chief Medical Officer Lykke Hinsch Gylvin said the company remains focused on developing new approaches for cardiovascular, renal and metabolic diseases while maintaining scientific rigor and patient safety.
Will Herrington, EASi-KIDNEY chief investigator at the University of Oxford, acknowledged the disappointing outcome and emphasized the continuing unmet medical need in CKD.
The remaining Phase III EASi studies will now provide the next major clinical readouts for vicadrostat and will help determine its potential across other cardiovascular and renal disease populations.
Reference
Boehringer provides update on EASi-KIDNEY trial, Boehringer Ingelheim, 15 September 2026
EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin), ClinicalTrials.gov ID NCT06531824
About the Writer
Saniya Sanjay Katakdhond (Linkedin) is a Doctor of Pharmacy professional with hands-on experience in patient case review, clinical documentation, medical record analysis, and patient care.
Her hospital experience has strengthened her understanding of clinical conditions, treatment approaches, and multidisciplinary healthcare practices.
With ICH-GCP certification and a research-oriented approach, she brings clinical insight and attention to detail to healthcare content development.
As a healthcare writer, Saniya focuses on translating clinical knowledge and patient-care experience into clear, accurate, and evidence-informed medical content.