Adding the investigational aldosterone synthase inhibitor baxdrostat to standard therapy reduced systolic blood pressure and urine albumin levels in patients with chronic kidney disease (CKD) and uncontrolled hypertension, according to results of the phase 2 FigHTN trial presented at the American Heart Association Hypertension Scientific Sessions and published simultaneously in the Journal of the American Society of Nephrology.
The multicenter trial enrolled 195 participants at 71 US sites. The average participant age was 66 years, 32% were women, 40% were non-Hispanic White, and 80% had type 2 diabetes. All participants had CKD with an estimated glomerular filtration rate of 25 to 75 mL/min/1.73 m², a urine albumin-creatinine ratio of 100 mg/g or greater, and uncontrolled hypertension (average systolic BP of 151 mm Hg) despite maximally tolerated treatment with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers.
One hundred ninety-two participants were randomly assigned to receive low-dose baxdrostat (0.5-1 mg), high-dose baxdrostat (2-4 mg), or placebo. After 26 weeks, systolic BP declined 8.1 mm Hg more with baxdrostat versus placebo, a reduction of about 5%.