A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure

Eligibility Criteria

• 1. Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.
• 2. Participants with:
• 1. eGFR ≥ 30 and \< 60 mL/min/1.73 m2 (local or central laboratory values) AND UACR ≥ 30 mg/g (3.39 mg/mmol) and \< 500 mg/g (56.5 mg/mmol) (central laboratory values only), or
• 2. eGFR ≥ 30 and ≤ 75 mL/min/1.73 m2 (local or central laboratory values) AND UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) or UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local or central laboratory values).
• 3. \[obsolete\]
• 4. Participants with history of HTN and a SBP ≥ 130 mmHg (the most recent value within 4 weeks prior to screening or at the Screening Visit) and ≥ 120 mmHg at the Randomisation Visit.
• 5. Stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit.
• 6. Participants with:
• 1. Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2 (local or central laboratory values).
• 2. Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR \< 45 mL/min/1.73 m2 (local or central laboratory values).
• 1. Systolic blood pressure \> 180 mmHg, or diastolic BP \> 110 mmHg at screening.
• 2. Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months prior to screening.
• 3. Serum sodium \< 135 mmol/L (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit).
• 4. T1DM:
• 1. 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.
• 2. 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.