RecruitingPhase 2NCT07222917
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.
A Phase IIb, Randomised, Multicentre, Double-Blind Study to Evaluate the Effect of Baxdrostat in Combination With Dapagliflozin Compared With Baxdrostat on Albuminuria in Participants With Chronic Kidney Disease and High Blood Pressure.
Sponsor
AstraZeneca
Enrollment
218 participants
Start Date
Dec 5, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria9
- 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.
Exclusion Criteria14
- 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
Interventions
DRUGBaxdrostat/dapagliflozin
baxdrostat tablet dapagliflozin tablet
DRUGBaxdrostat/Placebo
baxdrostat tablet placebo tablet
Locations(70)
View Full Details on ClinicalTrials.gov
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NCT07222917