A Phase IIb Study to Evaluate the Effect of Dapagliflozin in Combination With Baxdrostat Compared… (NCT07222917) | Clinical Trial Compass
RecruitingPhase 2
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.
United States218 participantsStarted 2025-12-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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:
What they're measuring
1
To determine whether baxdrostat/dapagliflozin is superior to baxdrostat/matching placebo at reducing albuminuria.
✕. 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