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.
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.
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).
T1DM at the screening visit
Parallel
Baxdrostat/dapagliflozin
Drugbaxdrostat tablet dapagliflozin tablet
Baxdrostat/Placebo
Drugbaxdrostat tablet placebo tablet
To determine whether baxdrostat/dapagliflozin is superior to baxdrostat/matching placebo at reducing albuminuria.
Change from baseline in UACR
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