Last updated 7 days ago

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.

2500 patients around the world

Available in Spain, Peru, Brazil, Argentina, United States

AstraZeneca

11Research sites

2500Patients around the world

This study is for people with

Renal disease

Chronic kidney disease

Arterial hypertension

Requirements for the patient

To 130 Years

All Gender

Medical requirements

: 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 ≥ 3.5 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

: Systolic blood pressure > 180 mmHg, or DBP > 110 mmHg at screening
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
Type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus with HbA1c > 10.5% (> 91 mmol/mol) at Screening
New York Heart Association functional HF class IV at screening
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
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
Any clinical condition requiring systemic immunosuppression therapy other than stable maintenance therapy for at least 3 months prior to Visit 1
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