Chronic kidney disease (CKD) affects over 850 million individuals globally, representing a substantial health burden due to its progressive nature and lack of definitive treatments. CKD often progresses to end-stage renal disease, necessitating dialysis or kidney transplantation, and significantly increases the risk of cardiovascular morbidity and mortality. Building on the EMPA-KIDNEY trial, which demonstrated the efficacy of empagliflozin in reducing the risk of kidney failure, dialysis, or cardiovascular death in CKD patients, the EASi-KIDNEY trial aims to evaluate the potential of BI 690517, an aldosterone synthase inhibitor, in further slowing the progression of CKD. Elevated aldosterone levels contribute to organ damage, hypertension, CKD, and heart failure, with BI 690517 targeting aldosterone synthase to inhibit aldosterone synthesis.

The EASi-KIDNEY trial is a phase III, multicenter, international, randomized, double-blind, placebo-controlled clinical study designed to assess the efficacy of BI 690517 in combination with empagliflozin in preventing CKD progression, reducing heart failure incidence, and decreasing cardiovascular-related mortality. The trial aims to enroll approximately 11,000 participants, including those with and without type 2 diabetes.

 Participants will be randomly assigned to receive either BI 690517 10mg daily or a matching placebo, both in conjunction with empagliflozin 10mg daily. The primary endpoints include time to the first occurrence of kidney disease progression (defined as kidney failure or a sustained ≥40% decline in eGFR from baseline), hospitalization for heart failure, or cardiovascular death. Secondary endpoints encompass the annual rate of change in eGFR, with pooled analysis key outcomes covering kidney failure, hospitalization for heart failure, cardiovascular death, all-cause hospitalization, and all-cause mortality.

 The study includes an 8-week run-in phase where participants receive placebo or BI 690517, followed by the initiation of empagliflozin 10mg. Participants will attend four clinic appointments in the first six months, followed by biannual visits thereafter. The trial duration is event-driven, continuing until the required number of participants have experienced their first primary outcome event. The Steering Committee will periodically review and may adjust the minimum number of primary outcome events based on interim analyses and adherence to ensure a robust assessment of BI 690517’s efficacy. This comprehensive evaluation is anticipated to span 3-4 years.

In India, the trial aims to enroll 1,250 participants across 21 sites, contributing to the global effort to establish a new therapeutic paradigm for CKD management by providing critical data on the combined use of BI 690517 and empagliflozin in mitigating CKD progression and associated cardiovascular risks.