Aprocitentan in Patients With Chronic Kidney Disease and Resistant Hypertension

Rossignol P, Clozel M, Dreier RF, Flack JM, Flamion B, Mann J, Narkiewicz K, Sassi-Sayadi M, Wang JG, Weber MA, Schlaich MP (2025)

Publication Type: Journal article

Publication year: 2025

Journal

Hypertension American Heart Association

Book Volume: 83

Journal Issue: 2

DOI: 10.1161/HYPERTENSIONAHA.125.25563

Abstract

BACKGROUND: Hypertension is a cause and consequence of chronic kidney disease (CKD). Resistant hypertension is common and often difficult to control in patients with CKD. This post hoc analysis evaluated the efficacy and safety of aprocitentan (with standardized background antihypertensive therapy) in patients with CKD and resistant hypertension, a group with high morbidity and mortality risk and limited treatment options. METHODS: The PRECISION study (Parallel-Group, Phase 3 Study With Aprocitentan in Subjects With Resistant Hypertension) consisted of part 1: 4-week, double-blind (aprocitentan 12.5 and 25 mg versus placebo); part 2: 32-week, single-blind (aprocitentan 25 mg); and part 3: 12-week, double-blind withdrawal (aprocitentan 25 mg versus placebo). In participants with CKD, aprocitentan's effect on blood pressure (BP), urine albumin-to-creatinine ratio, and safety was evaluated. RESULTS: Of 730 participants in PRECISION, 147 had CKD categorized as KDIGO high risk or very high risk. At week 4, aprocitentan 12.5 mg, aprocitentan 25 mg, and placebo reduced office systolic BP by -13.5, -16.6, and -4.4 mm Hg, respectively; this was maintained with aprocitentan 25 mg to week 36 (-16.4 mm Hg). At week 4, reductions in nighttime ambulatory systolic BP were -9.6, -13.8, and -2.5 mm Hg, respectively. Changes in urine albumin-to-creatinine ratio were -47.1%, -59.6%, and -2.4%, respectively, maintained with aprocitentan 25 mg to week 36 (-61.6%). Aprocitentan was generally well tolerated (no change in potassium or estimated glomerular filtration rate); early peripheral edema was the most common adverse event. CONCLUSIONS: Aprocitentan was well tolerated; efficiently lowered BP, particularly nighttime ambulatory BP; and markedly reduced urine albumin-to-creatinine ratio in participants with CKD and resistant hypertension. Aprocitentan may confer considerable cardiovascular and kidney-protective benefits in these difficult-to-treat patients. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03541174.

Involved external institutions

State University of New York at Albany (UNY Albany / UAlbany) US United States (USA) (US) Centre Hospitalier Régional et Universitaire de Nancy (CHRU de Nancy / CHU de Nancy) FR France (FR) Idorsia Pharmaceuticals Ltd CH Switzerland (CH) Novartis AG CH Switzerland (CH) Southern Illinois University US United States (USA) (US) Viatris Innovation GmbH CH Switzerland (CH) Medical University Gdansk / Gdański Uniwersytet Medyczny PL Poland (PL) Ruijin Hospital / 上海交通大学医学院附属瑞金医院 / St. Marie Hospital CN China (CN) Dobney Hypertension Centre AU Australia (AU)

How to cite

APA:

Rossignol, P., Clozel, M., Dreier, R.F., Flack, J.M., Flamion, B., Mann, J.,... Schlaich, M.P. (2026). Aprocitentan in Patients With Chronic Kidney Disease and Resistant Hypertension. Hypertension, 83(2). https://doi.org/10.1161/HYPERTENSIONAHA.125.25563

MLA:

Rossignol, Patrick, et al. "Aprocitentan in Patients With Chronic Kidney Disease and Resistant Hypertension." Hypertension 83.2 (2026).

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