A Phase IIb study to evaluate the effect of dapagliflozin in combination with baxdrostat compared with baxdrostat on albuminuria in participants with chronic kidney disease and high blood pressure. - BaxDuo-Baltic

Inclusion Criteria

• Inclusion 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​ eGFR ≥ 30 and < 90 mL/min/1.73 m2 at screening
• 3. Participants with UACR > 200 mg/g (22.6 mg/mmol) and < 5000 mg/g (565 mg/mmol) at screening
• 4. Participants with history of HTN and a SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the randomisation visit.
• 5. Stable and maximum daily tolerated dose of either an ACE inhibitor or an ARB (not both) for at least 4 weeks prior to the screening visit, if not medically contraindicated.​
• 6. Participants with:​
• (a) Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2.
• (b) Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR < 45 mL/min/1.73 m2.
• 7. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Applicable to female participants.​
• Exclusion Criteria:
• 1. Systolic blood pressure > 180 mmHg, or diastolic blood pressure > 110 mmHg at screening.​
• 2. Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months before screening​
• 3. Serum sodium < 135 mmol/L at the Screening Visit (values obtained within 4 weeks prior to screening or at the Screening Visit).​
• 4. Diabetes mellitus:
• (a) T1DM at the screening visit
• (b) Uncontrolled T2DM at screening: HbA1C > 10.5% (> 91 mmol/mol)
• 5. New York Heart Association functional HF class IV at screening​
• 6. Any use of mineralocorticoid receptor antagonists (such as spironolactone, eplerenone, or finerenone), aldosterone synthase inhibitors, 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​
• 7. Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, or carotid angioplasty, acute coronary syndrome, or hospitalisation for worsening HF within previous 3 months prior to randomisation.​
• 8. Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history.​
• 9. Documented history of adrenal insufficiency.​
• 10. Any dialysis (including for acute kidney injury) within 3 months prior to the screening ​
• 11. Any acute kidney injury within 3 months prior to the screening visit.
• 12. Prohibited concomitant medications