EASi-KIDNEY - Studies of Heart & Kidney Protection with BI 690517 in combination with empagliflozin: 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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511025-63-00

Acronym

1378-0006

Enrollment

2500

Registered

2024-07-30

Start date

2024-10-21

Completion date

Unknown

Last updated

2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease

Brief summary

Time to first occurrence of the primary composite outcome of: (i) Kidney disease progression (defined as kidney failure or a sustained decline of ≥40% in eGFR from randomization); or (ii) Hospitalization for heart failure; or (iii) Cardiovascular death.

Detailed description

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

Interventions

DRUGEMPAGLIFLOZIN

DRUGBI 690517

DRUGJardiance 10 mg film-coated tablets

DRUGPlacebo tablet matching BI690517

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to first occurrence of the primary composite outcome of: (i) Kidney disease progression (defined as kidney failure or a sustained decline of ≥40% in eGFR from randomization); or (ii) Hospitalization for heart failure; or (iii) Cardiovascular death.	—

Secondary

Measure	Time frame
Annual rate of change in eGFR from 3 months until last scheduled visit (i.e. chronic eGFR slope), Time to first event of kidney failure, hospitalization for heart failure or cardiovascular death, Time to kidney disease progression, Occurrences of hospitalizations for heart failure (first and any subsequent, combined) or cardiovascular death, Occurrences of hospitalizations from any cause (first and any subsequent, combined)	—

Measure

Time frame

—

Countries

Denmark, Germany, Italy, Portugal, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026