A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination with Dapagliflozin on CKD Progression in Participants with CKD and High blood pressure.

Exclusion Criteria

• 1. Systolic blood pressure > 180 mmHg, or DBP > 110 mmHg at screening.
• 2. Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening.
• 3. Serum sodium < 135 mmol/L at the Screening Visit, determined as per central laboratory.
• 4. Diabetes mellitus:
• (a) T1DM at Screening Visit:
• (i) For US only: patients with T1DM treated with SGLT2i for at least 4 months, without DKA during that period, and who have experience with ketone monitoring are eligible for inclusion.
• (ii) For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months, without DKA during the period of dapagliflozin treatment are eligible for inclusion.
• (b) Uncontrolled T2DM at screening: HbA1C > 10.5% (> 91 mmol/mol).
• 5. New York Heart Association functional HF class IV at screening.
• 6. Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, or carotid angioplasty, acute coronary syndrome, or hospitalisation for worsening heart failure within previous 3 months prior to randomisation.
• 7. Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.
• 8. Any acute kidney injury within 3 months prior to the Screening Visit
• 9. History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).
• 10. History or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2 inhibitor (eg, empagliflozin) or ASI.
• 11. Any clinical condition requiring systemic immunosuppression therapy other than stable maintenance therapy for at least 3 months prior to Visit 1.
• 12. Any use of mineralocorticoid receptor antagonists (such as spironolactone, eplerenone, or finerenone), potassium-sparing diuretics (such as triamterene or amiloride), or potassium binders (such as sodium zirconium cyclosilicate, patiromer, or sodium polystyrene sulfonate) within 4 weeks prior to screening.