When added to standard care, baxdrostat (CIN-107; AstraZeneca) shows benefits in managing high blood pressure and delaying the progression of kidney disease in patients with chronic kidney disease (CKD) and uncontrolled high blood pressure, according to preliminary research presented at the American Heart Association (AHA) Hypertension Scientific Sessions 2025.1
These findings, which are from the phase 2 FigHTN clinical trial (NCT05432167)2, further reaffirm the benefits of baxdrostat when managing blood pressure, such as those demonstrated in the phase 3 BaxHTN trial (NCT06034743).1,3
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About the Trial
Trial Name: A Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease
ClinicalTrials.gov ID: NCT05432167
Sponsor: AstraZeneca
Completion Date: May 2, 2024
CKD and high blood pressure are closely linked, according to the investigators, and if not managed properly or left untreated, patients can experience serious outcomes such as heart attack, stroke, heart failure, and progression to kidney failure. According to the manufacturers, baxdrostat is a potential first-in-class, highly selective, potent oral small molecule that inhibits aldosterone synthase, an enzyme encoded by the CYP11B2 gene, which is responsible for the synthesis of aldosterone in the adrenal gland. Baxdrostat is currently undergoing investigation in clinical trials as a monotherapy for hypertension and primary aldosteronism and as a combination therapy for CKD and the prevention of heart failure in patients with hypertension.1,4
“These findings are encouraging for people living with CKD and high blood pressure, 2 conditions that often go hand-in-hand and create a dangerous cycle,” lead study author Jamie P. Dwyer, MD, professor of medicine in the division of nephrology and hypertension at University of Utah Health in Salt Lake City, said in a news release. “High blood pressure can worsen kidney function and declining kidney function can further elevate blood pressure, and these outcomes can be life-altering for patients.”1
FigHTN is a randomized, double-blind, placebo-controlled phase 2 clinical trial that assessed whether adding baxdrostat to standard care is safe and could lower blood pressure in patients who have both CKD and uncontrolled hypertension. The enrolled patients’ blood pressure remained high even after receiving prior treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker.1,2
A total of 192 patients (average age: 66 years) with CKD and hypertension were randomly assigned to receive treatment with a low dose (0.5 mg–1 mg) or high dose of baxdrostat (2 mg–4 mg) or placebo in addition to standard care for a 26-week duration. The primary end point was change from baseline in mean seated office systolic blood pressure at week 26 in the baxdrostat pooled treatment group compared with placebo, and the secondary end point assessed this change by high-dose or low-dose baxdrostat. Additionally, safety outcomes were also evaluated. The findings were presented at the AHA Hypertension Scientific Sessions 2025 and published in the Journal of the American Society of Nephrology.1,2,5
The data show that the mean baseline systolic blood pressure was about 151.2 mmHg, the mean baseline estimated glomerular filtration rate was 44 ml/min/1.73 m2, and the median urine albumin-creatinine ratio was 713.8 mg/g. The mean placebo-corrected change in systolic blood pressure from baseline to week 26 for the baxdrostat pooled group was –8.1 (95% CI: −13.4 to −2.8; P = .003) mmHg, and for low-dose and high-dose, these were −9.0 (95% CI: −15.1 to −2.9; P = .004) mmHg and −7.2 (95% CI: −13.2 to −1.2; P = 0.02) mmHg, respectively.1,5
Importantly, there were no deaths or unexpected adverse events (AEs) throughout the study population. Hyperkalemia was the most common AE and was observed in approximately 41% (n = 53) of participants in the baxdrostat pooled group and 5% (n = 3) in the placebo group.1,5
“These new findings are reassuring that this new class of antihypertensive medications are likely to have both kidney- and cardioprotective benefits and to be safe and effective for broad patient populations,” Jordana B. Cohen, MD, MSCE, immediate past chair of the AHA’s Hypertension and Kidney Cardiovascular Science Committee, and deputy director and associate professor of medicine and epidemiology in the Perelman School of Medicine at the University of Pennsylvania, said in the news release. “Patients with CKD were historically often excluded from drug studies. It is particularly reassuring to know that patients with CKD, who have very high rates of hypertension and elevated renin-angiotensin aldosterone activity, were represented in their own study, tolerated the medication well, and had both blood pressure and albuminuric benefits. This medication class could be a game changer in the management of hypertension in this patient group.”1