Last updated 54 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
1Research 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 screeningUrine albumin creatinine ratio > 200 mg/g (22.6 mg/mmol) and < 5000 mg/g (565 mg/mmol) at screeningParticipants with history of HTN and a SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the randomisation visitStable and maximum tolerated dose of an ACE inhibitor or an ARB (not both) for at least 4 weeks prior to Screening VisitCentral 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 Visitfor 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 screeningKnown hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screeningSerum sodium < 135 mmol/L at the Screening Visit, determined as per central laboratoryType 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus with HbA1c > 10.5% (> 91 mmol/mol) at ScreeningNew York Heart Association functional HF class IV at screeningStroke, 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 randomisationAny dialysis (including for acute kidney injury) within 3 months prior to Screening VisitAny acute kidney injury within 3 months prior to the Screening VisitHistory 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 ASIAny clinical condition requiring systemic immunosuppression therapy other than stable maintenance therapy for at least 3 months prior to Visit 1Any 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
Sites
STAT Research - CABA
Recruiting
SponsorAstraZeneca
Conditions
Chronic kidney diseaseArterial hypertension
Requirements
To 130 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06268873
