A Phase IIb study to evaluate the effect of combination of dapagliflozin and baxdrostat compared with baxdrostat alone in participants with chronic kidney disease and high blood pressure

Prior treatment

• Any dialysis (including for acute kidney injury) within 3 months prior to the screening
• Any acute kidney injury within 3 months prior to the screening visit.
• Prohibited concomitant medications
• 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.

Other illness

• New York Heart Association functional HF class IV at screening
• Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history.
• Documented history of adrenal insufficiency.

Lab values

• Known hyperkalaemia, defined as potassium of ≥ 5.5mmol/L within 3 months before screening
• Serum sodium < 135 mmol/L at the Screening Visit (values obtained within 4 weeks prior to screening or at the Screening Visit).
• Diabetes mellitus: (a) T1DM at the screening visit (b) Uncontrolled T2DM at screening: HbA1C > 10.5% (> 91mmol/mol)
• Any use of mineralocorticoid receptor antagonists, aldosterone synthase inhibitors, potassium-sparing diuretics, or potassium binders within 4 weeks prior to screening

Other

• Systolic blood pressure > 180 mmHg, or diastolic blood pressure > 110 mmHg at screening.

• Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.
• Participants with eGFR ≥ 30 and < 90 mL/min/1.73 m2 at screening
• Participants with UACR > 200 mg/g (22.6 mg/mmol) and < 5000 mg/g (565 mg/mmol) at screening
• Participants with history of HTN and a SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the randomisation visit.
• 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.
• 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.
• Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Applicable to female participants.