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.

Phase 3

Recruiting

Conditions: Chronic Kidney Disease and Hypertension

Registration Number: NCT06268873

Lead Sponsor: AstraZeneca

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria: 1. Participants of any sex and gender must be = 18 years old, or older, at the time of signing the informed consent. 2. Participants with CKD and eGFR = 30 and < 90 mL/min/1.73 m2 at screening 3. Urine albumin creatinine ratio > 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 tolerated dose of an ACE inhibitor or an ARB (not both) for at least 4 weeks prior to Screening Visit 6. 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 = 3.5 and = 4.8 mmol/L at the Screening Visit - for participants with screening eGFR < 45 mL/min/1.73 m2, potassium must be = 3.5 and = 4.5 mmol/L at the Screening Visit 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. Type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus with HbA1c > 10.5% (> 91 mmol/mol) at Screening. 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.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone to slow CKD progression, assessed as the effect on change in eGFR over time.

Secondary Outcome Measures

Name	Time	Method
To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing UACR (urine albumin-creatinine ratio).;To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing SBP.;To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows CKD progression and reduces the risk of ESKD (End-stage kidney disease).;To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows the rate of kidney function decline after the hemodynamically-mediated acute effect on GFR (Glomerular Filtration Rate).