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.

Part of paid clinical trials in Surprise, Arizona.

Sponsor
AstraZeneca
Study ID
NCT07222917
Phase
PHASE2
Status
Recruiting
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Conditions

  • Chronic Kidney Disease and Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
Dec 5, 2025
Status verified
May 2026
Primary completion
May 24, 2027
Completion
May 24, 2027

Study Design

Enrollment
218 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Baxdrostat/dapagliflozin
    Participants randomised to the baxdrostat/dapagliflozin arm will receive one dose of baxdrostat and one standard dose of dapagliflozin daily.
  • Placebo Comparator: Baxdrostat /placebo
    Patients will receive one dose of baxdrostat comparator in combination with placebo matching dapagliflozin daily

Primary Outcome Measure

To determine whether baxdrostat/dapagliflozin is superior to baxdrostat/matching placebo at reducing albuminuria. [ Time Frame: Up to 12 weeks ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
Research SiteSurpriseArizona85374-
Research SiteHollywoodFlorida33021-
Research SitePort CharlotteFlorida33952-
Research SitePort OrangeFlorida32127-
Research SiteAtlantaGeorgia30344-
Research SiteChampaignIllinois61822-
Research SiteWichitaKansas67214-
Research SiteEatontownNew Jersey07724-
Research SiteGreenvilleNorth Carolina27834-
Research SiteJacksonvilleNorth Carolina28546-
Research SiteNew BernNorth Carolina28562-
Research SiteColumbusOhio43215-
Research SiteMediaPennsylvania19063-
Research SiteEast ProvidenceRhode Island02914-
Research SiteArlingtonTexas76015-
Research SitePasadenaTexas77504-
Research SiteSan AntonioTexas78212-
Research SiteWoodbridgeVirginia22192-

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