J Am Soc Nephrol
Novel drug lowers blood pressure in CKD patients with uncontrolled hypertension
Study details: This phase 2, randomized, double-blind, placebo-controlled multicenter trial (NCT05432167) evaluated baxdrostat, an aldosterone synthase inhibitor, in 195 adults with chronic kidney disease (CKD) and uncontrolled hypertension. Participants were on ACE inhibitors or ARBs and had elevated systolic BP and albuminuria. They were randomized to low-dose (0.5–1 mg) baxdrostat, high-dose (2–4 mg) baxdrostat, or placebo for 26 weeks. Primary endpoint was change in seated office systolic BP at week 26.
Results: The mean baseline systolic BP was 151.2 mm Hg; the mean baseline eGFR was 44 mL/min per 1.73 m2, and the median urine albumin-creatinine ratio was 713.8 mg/g. Baxdrostat significantly reduced systolic BP vs. placebo: –8.1 mm Hg baxdrostat pooled group (95% confidence interval [CI], −13.4 to −2.8; P=0.003), –9.0 mm Hg low-dose group (CI, −15.1 to −2.9; P=0.004), and –7.2 mm Hg high-dose group (CI −13.2 to −1.2; P=0.02). Hyperkalemia occurred in 41% of baxdrostat-treated participants vs. 5% in the placebo group.
Clinical impact: Baxdrostat offers a promising new mechanism for BP control in CKD patients with resistant hypertension. However, the high rate of hyperkalemia warrants close monitoring and may limit its use.
Source:
Dwyer JP, et al. (2025, September 6). J Am Soc Nephrol. Efficacy and Safety of Baxdrostat in Participants with CKD and Uncontrolled Hypertension: A Randomized, Double-Blind, Placebo-Controlled Trial. https://pubmed.ncbi.nlm.nih.gov/40913594/