Baxdrostat/Dapagliflozin Renal Outcomes Study (BaxDuo-Pacific)

Study Overview

A Phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of baxdrostat (an aldosterone synthase inhibitor) in combination with dapagliflozin compared to dapagliflozin alone. The study aims to reduce the risk of the composite endpoint of ≥50% sustained decline in eGFR, kidney failure, or cardiovascular death in participants with CKD and high blood pressure.

Inclusion Criteria

• ✓Adults aged 18 years or older with CKD and hypertension
• ✓eGFR ≥30 and ≤75 mL/min/1.73 m²
• ✓UACR ≥30 and ≤5000 mg/g
• ✓SBP ≥130 mmHg at screening and ≥120 mmHg at randomization
• ✓On stable ACEi or ARB therapy for at least 4 weeks prior to screening
• ✓Potassium ≥3.0 and ≤4.8 mmol/L (≤4.5 mmol/L for participants with eGFR <45)

Exclusion Criteria

• ✗Severe hepatic impairment
• ✗Type 1 diabetes
• ✗Prior kidney transplant or on dialysis
• ✗Known hypersensitivity to baxdrostat or dapagliflozin
• ✗Current use of potassium-sparing diuretics or MRAs