RecruitingChronic Kidney Disease and Hypertension

A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure

Eligible age

18+ yrs

Accepts

All genders

Locations

34 states

Healthy volunteers

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About this study

International, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure

Sponsor: AstraZeneca

You may qualify if…

✓ 1. Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.
✓ 2. Participants with (a) or (b):
✓ a) eGFR 30-59 mL/min/1.73 m² (local or central laboratory value) AND:
✓ UACR ≥ 30 mg/g (3.39 mg/mmol) and \< 500 mg/g (56.5 mg/mmol) (central laboratory value only), or
✓ UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or
✓ UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only).
✓ (b) eGFR 60-75 mL/min/1.73 m² (local or central laboratory value) AND:
✓ UACR ≥ 500 mg/g (56.5 mg/mmol) ) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or

You may not qualify if…

✕ 1. Systolic blood pressure \> 180 mmHg, or diastolic BP \> 110 mmHg at screening.
✕ 2. Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening.
✕ 3. Serum sodium \< 135 mmol/L (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit).
✕ 4\. Participants with T1DM will be excluded, except:
✕ 1. For US only: patients with T1DM treated with SGLT2i for at least 4 months, without DKA during that period, and who have experience with ketone monitoring are eligible for inclusion.
✕ 2. For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months, without DKA during the period of dapagliflozin treatment are eligible for inclusion.
✕ 5 Uncontrolled T2DM with HbA1c \> 10.5% (\> 91 mmol/mol) (central or local laboratory values obtained within 3 months prior to screening or at the Screening Visit).
✕ 6 New York Heart Association functional HF class IV at screening.