A Phase IIb Study to Evaluate the Effect of Dapagliflozin in Combination With Baxdrostat Compared With Baxdrostat on Albuminuria in Participants With Chronic Kidney Disease and High Blood Pressure.

What this study is about

International, Multicenter and Double-Blind study. The purpose is to measure the effect of baxdrostat in combination with dapagliflozin compared with baxdrostat/placebo on albuminuria, as well as safety, in participants with chronic kidney disease and high blood pressure.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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:
  • Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2.
  • 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.

🚫 You may not be able to join if…

• Systolic blood pressure > 180 mmHg, or diastolic blood pressure > 110 mmHg at screening.
• Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/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:
  • T1DM at the screening visit
  • Uncontrolled T2DM at screening: HbA1C > 10.5% (> 91 mmol/mol)
• New York Heart Association functional HF class IV at screening
• Any use of mineralocorticoid receptor antagonists (such as spironolactone, eplerenone, or finerenone), aldosterone synthase inhibitors, 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
• 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.
• Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history.
• Documented history of adrenal insufficiency.
• 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

Where this trial is running

• Research Site, Surprise, Arizona, United States
• Research Site, Hollywood, Florida, United States
• Research Site, Port Charlotte, Florida, United States
• Research Site, Port Orange, Florida, United States
• Research Site, Atlanta, Georgia, United States
• Research Site, Champaign, Illinois, United States
• Research Site, Wichita, Kansas, United States
• Research Site, Eatontown, New Jersey, United States
• Research Site, Greenville, North Carolina, United States
• Research Site, Jacksonville, North Carolina, United States
• Research Site, New Bern, North Carolina, United States
• Research Site, Columbus, Ohio, United States

+ 59 more sites.

Who to contact

AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07222917.