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.

Korábbi kezelés

• 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.
• Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.
• Any acute kidney injury within 3 months prior to the Screening Visit
• Any clinical condition requiring systemic immunosuppression therapy other than stable maintenance therapy for at least 3 months prior to Visit 1.

Más betegség

• New York Heart Association functional HF class IV at screening.
• History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).
• History or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2 inhibitor (eg, empagliflozin) or ASI.

Laborértékek

• Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening.
• Serum sodium < 135 mmol/L at the Screening Visit, determined as per central laboratory.
• 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).
• 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.

Egyéb

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

• Participants of any sex and gender must be ≥ 18 years old, or older, at the time of signing the informed consent.
• Participants with CKD and eGFR ≥ 30 and < 90 mL/min/1.73 m2 at screening
• Urine albumin creatinine ratio > 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 tolerated dose of an ACE inhibitor or an ARB (not both) for at least 4 weeks prior to Screening Visit
• Central laboratory serum potassium must meet the following criteria at the Screening Visit, based on screening eGFR:
  • for participants with screening eGFR ≥ 45 mL/min/1.73 m2, potassium must be ≥ 3.0 and ≤ 4.8 mmol/L at the Screening Visit
  • for participants with screening eGFR < 45 mL/min/1.73 m2, potassium must be ≥ 3.0 and ≤ 4.5 mmol/L at the Screening Visit