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.

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Chronic Kidney Disease and Hypertension

In brief

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.

Key facts

Study ID

NCT07222917

Run by

AstraZeneca

People needed

218

Starts

2025-12-05

Expected to finish

2027-05-24

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• Research Site — Surprise, Arizona, United States (enrolling)
• Research Site — Yambol, Bulgaria (enrolling)
• Research Site — Hollywood, Florida, United States (enrolling)
• Research Site — Atlanta, Georgia, United States (enrolling)
• Research Site — Sofia, Bulgaria (enrolling)
• Research Site — Wichita, Kansas, United States (enrolling)
• Research Site — Eatontown, New Jersey, United States (enrolling)
• Research Site — Port Orange, Florida, United States (enrolling)
• Research Site — Jacksonville, North Carolina, United States (enrolling)
• Research Site — New Bern, North Carolina, United States (enrolling)
• Research Site — Port Charlotte, Florida, United States (enrolling)
• Research Site — Media, Pennsylvania, United States (enrolling)
• Research Site — East Providence, Rhode Island, United States (enrolling)
• Research Site — Arlington, Texas, United States (enrolling)
• Research Site — Pasadena, Texas, United States (enrolling)
• Research Site — San Antonio, Texas, United States (enrolling)
• Research Site — Woodbridge, Virginia, United States (enrolling)
• Research Site — Greenville, North Carolina, United States (enrolling)
• Research Site — Ciudad de Buenos Aires, Argentina (enrolling)
• Research Site — Mar del Plata, Argentina (enrolling)
• Research Site — Rosario, Argentina (enrolling)
• Research Site — San Nicolás, Argentina (enrolling)
• Research Site — Columbus, Ohio, United States (enrolling)
• Research Site — Champaign, Illinois, United States (enrolling)
• Research Site — Courtice, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.