Efficacy and safety of aldosterone synthase inhibition with and without empagliflozin for chronic kidney disease: a randomised, controlled, phase 2 trial.

Document Type

Article

Publication Date

1-27-2024

Publication Title

Lancet

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

Department

Nephrology

Department

Endocrinology

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