The following is a summary of “Study Design and Baseline Characteristics for Aldosterone Synthase Inhibition in CKD,” published in the October 2023 issue of Nephrology by Tuttle et al. 

Researchers performed a retrospective study to investigate BI 690517, an aldosterone synthase(AS) inhibitor, to treat chronic kidney disease (CKD). 

The efficacy and safety of daily oral BI 690517, with or without empagliflozin 10 mg, were investigated in CKD patients. The primary endpoint was the change from baseline in urine albumin: creatinine ratio (UACR) at week 14. About 714 adults previously treated with an angiotensin-converting enzyme inhibitor (30.5%) or angiotensin receptor blocker (69.8%) were randomized (1:1) to an 8-week run-in with background empagliflozin (n = 356) or placebo (n = 358). Following the run-in, participants in each group were randomized (1:1:1:1) to a 14-week treatment period with BI 690517 (3 mg, 10 mg, or 20 mg) or placebo. 

Of the 714 participants in the run-in phase, 586 were randomized to the treatment period. These participants were predominantly men (66.6%) of the White race (58.4%), with a mean (SD age of 63.8 (11.3) years. Type 2 diabetes was present in 414 participants (70.6%). The baseline mean (SD) estimated glomerular filtration rate(EGFR) was 51.9 (17.7) mL/min/1.73 m², and the median (interquartile range) UACR was 426.3 mg/g (205.3–888.5).

This study will inform dosing and determine if BI 690517, with or without empagliflozin, is safe and effective in CKD patients on a renin-angiotensin system inhibitor.

Source: karger.com/ajn/article/doi/10.1159/000534808/868946/Study-Design-and-Baseline-Characteristics-for