Phase 3 trial of vicadrostat in CKD discontinued early
The phase 3 EASi-KIDNEY trial evaluating vicadrostat in addition to empagliflozin in patients with CKD will be discontinued early. Accumulating data did not support a meaningful expectation of clinical benefit on the primary composite endpoint with vicadrostat plus empagliflozin compared with empagliflozin alone.
The decision to discontinue EASi-KIDNEY followed a recommendation from the trial’s independent Data Monitoring Committee (DMC) and a benefit-risk assessment of the available data.
EASi-KIDNEY was an international, randomized, double-blind, placebo-controlled phase 3 trial evaluating whether the addition of vicadrostat (BI 690517), an investigational aldosterone synthase inhibitor, to empagliflozin could reduce kidney and CV events in patients with CKD at risk of progression.
The primary endpoint was time to first occurrence of a composite of kidney disease progression, hospitalization for HF, or CV death. Kidney disease progression was defined as kidney failure or a sustained ≥40% decline in eGFR from randomization.
The trial planned to enroll approximately 11,000 participants. All participants received empagliflozin once daily and were randomized to vicadrostat once daily or placebo.
Three other phase 3 trials of vicadrostat plus empagliflozin in the EASi clinical program—EASi-HF Reduced, EASi-HF Preserved and EASi-PROTKT—will continue without modification following recommendations from their respective DMCs.