Efficacy and safety of aldosterone synthase inhibition with and without empagliflozin for chronic kidney disease: a randomised, controlled, phase 2 trial.
Publication Title
Lancet
Document Type
Article
Publication Date
1-27-2024
Keywords
Aged; Female; Humans; Male; Middle Aged; Benzhydryl Compounds; Cytochrome P-450 CYP11B2; Double-Blind Method; Glucosides; Hyperkalemia; Mineralocorticoid Receptor Antagonists; Renal Insufficiency, Chronic; Treatment Outcome; spokane; washington
Abstract
BACKGROUND: Excess aldosterone accelerates chronic kidney disease progression. This phase 2 clinical trial assessed BI 690517, an aldosterone synthase inhibitor, for efficacy, safety, and dose selection.
METHODS: This was a multinational, randomised, controlled, phase 2 trial. People aged 18 years or older with an estimated glomerular filtration rate (eGFR) of 30 to less than 90 mL/min/1·73 m
FINDINGS: Between Feb 18 and Dec 30, 2022, of the 714 run-in participants, 586 were randomly assigned to receive BI 690517 or placebo. At baseline, 33% (n=196) were women, 67% (n=390) were men, 42% (n=244) had a racial identity other than White, and mean participant age was 63·8 years (SD 11·3). Mean baseline eGFR was 51·9 mL/min/1·73 m
INTERPRETATION: BI 690517 dose-dependently reduced albuminuria with concurrent renin-angiotensin system inhibition and empagliflozin, suggesting an additive efficacy for chronic kidney disease treatment without unexpected safety signals.
FUNDING: Boehringer Ingelheim.
Clinical Institute
Kidney & Diabetes
Specialty/Research Institute
Nephrology
Specialty/Research Institute
Endocrinology
DOI
10.1016/S0140-6736(23)02408-X
