Kidney Week

Abstract: FR-PO0488

Baxdrostat/Dapagliflozin vs. Placebo/Dapagliflozin in Adults with CKD with Hypertension: BaxDuo-Arctic Phase 3 Study Design and Baseline Characteristics

Session Information

• CKM: Clinical - Trials, Epidemiology, and Biomarkers
  October 23, 2026 | Location: Exhibit Hall A, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Cardiovascular-Kidney-Metabolic Health

• 602 Cardiovascular-Kidney-Metabolic Health: Clinical

Authors

• Heerspink, Hiddo Jan L., The George Institute for Global Health, University of New South Wales, Sydney, Australia

Hiddo Jan L. Heerspink, PharmD, PhD

• Balliu, Natalja, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Stockholm, Sweden

Natalja Balliu, MSc

• Bansal, Nisha, Division of Nephrology, Department of Medicine, University of Washington, Seattle, Washington, United States

Nisha Bansal, MD, FASN

• Dwyer, Jamie P., Division of Nephrology and Hypertension, University of Utah, Salt Lake City, Utah, United States

Jamie P. Dwyer, MD

• Eckardt, Kai-Uwe, Department of Nephrology and Medical Intensive Care, Charité-Universitätsmedizin Berlin, Berlin, Germany

Kai-Uwe Eckardt, MD

• Lam, Carolyn S.P., National Heart Centre Singapore, Singapore, Singapore

Carolyn S.P. Lam, MBBS, PhD

• Lewis, Eldrin F., Division of Cardiovascular Medicine, Department of Medicine, Stanford University School of Medicine, Palo Alto, California, United States

Eldrin F. Lewis, MD

• Little, Dustin J., Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, United States

Dustin J. Little, MD

• Myte, Robin, Biometrics, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden

Robin Myte, PhD

• Neuen, Brendon Lange, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia

Brendon Lange Neuen, MBBS, MS, PhD, FASN

• Rossignol, Patrick, Université de Lorraine, INSERM, Centre d'Investigations Cliniques-Plurithématique 1433, INSERM Unit 1116, Centre Hospitalier Régional Universitaire (CHRU) de Nancy, and F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France

Patrick Rossignol, MD

• Tangri, Navdeep, Department of Internal Medicine, University of Manitoba, Seven Oaks General Hospital, Winnipeg, Manitoba, Canada

Navdeep Tangri, MD, PhD

• Tapia Silva, Leticia Mirell, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden

Leticia Mirell Tapia Silva, MD

• Zaozerska, Nataliia, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Warsaw, Poland

Nataliia Zaozerska, MD, PhD

• Chertow, Glenn M., Departments of Medicine, Epidemiology and Population Health, and Health Policy, Stanford University School of Medicine, Stanford, California, United States

Glenn M. Chertow, MD, MPH, FASN

Background

Baxdrostat is a selective aldosterone synthase inhibitor that is being developed as a fixed-dose combination with the sodium-glucose cotransporter-2 inhibitor (SGLT2i) dapagliflozin for the treatment of chronic kidney disease (CKD) with hypertension. We report the design and baseline characteristics of the phase 3, randomized, double-blind BaxDuo-Arctic study (NCT06268873).

Methods

Eligible adults have seated systolic blood pressure (sSBP) ≥130 mmHg, estimated glomerular filtration rate (eGFR) ≥30 to <90 mL/min/1.73 m², and urine albumin creatinine ratio (UACR) >200 to <5000 mg/g at screening, despite angiotensin-converting enzyme inhibitor or angiotensin receptor blocker treatment at maximally tolerated dose for ≥4 weeks. Patients with no prior use or <4 weeks of SGLT2i treatment will complete a run-in with dapagliflozin 10 mg once daily (QD) for 4–6 weeks. Patients are randomized 1:1 to receive baxdrostat 1 mg/dapagliflozin 10 mg or placebo/dapagliflozin 10 mg QD for a 104-week double-blind period, followed by a 12-week open-label period with dapagliflozin 10 mg QD. Baxdrostat dose can be uptitrated to 2 mg at week 8 if blood potassium is ≤4.8 mmol/L between week 2 and 8. The primary endpoint is change in eGFR from baseline to the end of the 12-week open-label dapagliflozin period. Adverse events of special interest include hyperkalemia, hyponatremia, and hypotension events that require medical intervention.

Results

Between March 2024 and November 2025, 2554 patients in 38 countries were randomized. Among 2534 randomized patients with available data at time of submission, 71% were male, 58% had type 2 diabetes, 66% used an SGLT2i at screening, and 71% were on ≥2 antihypertensive medications. Common causes of CKD in patients included diabetic kidney disease (36%), chronic glomerulonephritis (20%), and ischemic/hypertensive nephropathy (18%). Median UACR was 868.0 mg/g. Mean (standard deviation) eGFR and sSBP were 57.3 (15.7) mL/min/1.73 m² and 140.8 (13.9) mmHg, respectively.

Conclusion

BaxDuo-Arctic will assess the efficacy and safety of baxdrostat/dapagliflozin versus placebo/dapagliflozin on CKD progression in patients with CKD with hypertension.

Acknowledgment

The BaxDuo-Arctic (NCT06268873) study is sponsored by AstraZeneca. Medical writing support, under the direction of the authors, was provided by Katherine Wood, PhD, of Ashfield MedComms, an Inizio Company, and was funded by AstraZeneca, in accordance with Good Publication Practice guidelines (https://www.ismpp.org/gpp-2022).

Funding

• Commercial Support – AstraZeneca