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

Part of paid clinical trials in Fairhope, Alabama.

Sponsor
AstraZeneca
Study ID
NCT06742723
Phase
PHASE3
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, 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

Key Dates

Start date
Mar 3, 2025
Status verified
May 2026
Primary completion
Dec 18, 2029
Completion
Dec 18, 2029

Study Design

Enrollment
5,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Baxdrostat/dapagliflozin
    Participants randomised to the baxdrostat/dapagliflozin arm will initially receive a lower dose of baxdrostat and standard dose dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose.
  • Placebo Comparator: Placebo/dapagliflozin
    Patients will receive one dose of dapagliflozin comparator in combination with matching placebo daily.

Primary Outcome Measure

To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure, Heart Failure events(HF), or CV death. [ Time Frame: Up to 37 months ]

Central Contacts

Locations (132)

FacilityCityStateZIPSite coordinators
Research SiteFairhopeAlabama36532-
Research SiteSurpriseArizona85374-
Research SiteTucsonArizona85710-
Research SiteBeverly HillsCalifornia90211-
Research SiteCanoga ParkCalifornia91303-
Research SiteConcordCalifornia94520-
Research SiteFremontCalifornia94538-
Research SiteFullertonCalifornia92835-
Research SiteInglewoodCalifornia90301-
Research SiteLos AlamitosCalifornia90720-
Research SiteLos AngelesCalifornia90073-
Research SiteSan DiegoCalifornia92120-
Research SiteSan FranciscoCalifornia94110-
Research SiteStanfordCalifornia94305-
Research SiteTarzanaCalifornia91356-
Research SiteArvadaColorado80002-
Research SiteDenverColorado80220-
Research SiteNew BritainConnecticut06051-
Research SiteWashington D.C.District of Columbia20037-
Research SiteBoca RatonFlorida33487-
Research SiteBoynton BeachFlorida33435-
Research SiteEdgewaterFlorida32132-
Research SiteFort LauderdaleFlorida33316-
Research SiteHollywoodFlorida33021-
Research SiteJacksonville BeachFlorida32250-
Research SiteLake CityFlorida32055-
Research SiteLakelandFlorida33805-
Research SiteMelbourneFlorida32901-
Research SiteMiami LakesFlorida33014-
Research SiteOcoeeFlorida34761-
Research SitePort CharlotteFlorida33952-
Research SitePort OrangeFlorida32127-
Research SiteRiverviewFlorida33578-
Research SiteAtlantaGeorgia30328-
Research SiteAtlantaGeorgia30344-
Research SiteAugustaGeorgia30904-
Research SiteAustellGeorgia30106-
Research SiteBrunswickGeorgia31520-
Research SiteConyersGeorgia30094-
Research SiteDecaturGeorgia30030-
Research SiteLawrencevilleGeorgia30046-
Research SiteRiverdaleGeorgia30274-
Research SiteHonoluluHawaii96814-
Research SiteChampaignIllinois61822-
Research SiteMaywoodIllinois60153-
Research SiteRockfordIllinois61107-
Research SiteEvansvilleIndiana47714-
Research SiteIndianapolisIndiana46202-
Research SiteIowa CityIowa52242-
Research SiteWest Des MoinesIowa50266-
Research SiteHutchinsonKansas67502-
Research SiteKansas CityKansas66112-
Research SiteWichitaKansas67214-
Research SiteKennerLouisiana70065-
Research SiteMetairieLouisiana70006-
Research SiteWest MonroeLouisiana71291-
Research SiteBethesdaMaryland20889-
Research SiteBostonMassachusetts02114-
Research SiteBostonMassachusetts02115-
Research SiteBraintreeMassachusetts02184-
Research SiteNew BedfordMassachusetts02740-
Research SiteWorcesterMassachusetts01608-
Research SiteAnn ArborMichigan48109-
Research SiteDetroitMichigan48202-
Research SiteGarden CityMichigan48135-
Research SiteSaint JosephMichigan49085-
Research SiteKansas CityMissouri64111-
Research SiteKansas CityMissouri64151-
Research SiteSt LouisMissouri63136-
Research SiteNorfolkNebraska68701-
Research SiteLas VegasNevada89109-
Research SiteEatontownNew Jersey07724-
Research SiteAlbanyNew York12205-
Research SiteBuffaloNew York14203-
Research SiteNew YorkNew York10016-
Research SiteGreenvilleNorth Carolina27834-
Research SiteHickoryNorth Carolina28601-
Research SiteJacksonvilleNorth Carolina28546-
Research SiteKinstonNorth Carolina28504-
Research SiteMorehead CityNorth Carolina28557-
Research SiteNew BernNorth Carolina28562-
Research SiteRaleighNorth Carolina27609-
Research SiteRocky MountNorth Carolina27804-
Research SiteSanfordNorth Carolina27330-
Research SiteStatesvilleNorth Carolina28625-
Research SiteWilmingtonNorth Carolina28401-
Research SiteWilmingtonNorth Carolina28412-
Research SiteWinston-SalemNorth Carolina27103-
Research SiteCantonOhio44718-
Research SiteCincinnatiOhio45212-
Research SiteCincinnatiOhio45219-
Research SiteColumbusOhio43210-
Research SiteColumbusOhio43213-
Research SiteColumbusOhio43215-
Research SiteSpringfieldOregon97477-
Research SiteBridgevillePennsylvania15017-
Research SiteButlerPennsylvania16001-
Research SiteExtonPennsylvania19341-
Research SiteLanghornePennsylvania19047-
Research SiteMediaPennsylvania19063-
Research SiteEast ProvidenceRhode Island02914-
Research SiteEast ProvidenceRhode Island02915-
Research SiteProvidenceRhode Island02904-
Research SiteCharlestonSouth Carolina29414-
Research SiteColumbiaSouth Carolina29203-
Research SiteOrangeburgSouth Carolina29118-
Research SiteChattanoogaTennessee37421-
Research SiteKnoxvilleTennessee37912-
Research SiteKnoxvilleTennessee37938-
Research SiteNashvilleTennessee37232-
Research SiteArlingtonTexas76015-
Research SiteAustinTexas78726-
Research SiteAustinTexas78735-
Research SiteAustinTexas78751-
Research SiteDallasTexas75230-
Research SiteDallasTexas75234-
Research SiteDallasTexas75246-
Research SiteHoustonTexas77004-
Research SiteHoustonTexas77099-
Research SiteHumbleTexas77346-
Research SiteLewisvilleTexas75057-
Research SitePasadenaTexas77504-
Research SitePearlandTexas77584-
Research SiteSan AntonioTexas78212-
Research SiteSouth Salt LakeUtah84115-
Research SiteBurlingtonVermont05401-
Research SiteArlingtonVirginia22205-
Research SiteManassasVirginia20110-
Research SiteNewport NewsVirginia23606-
Research SiteRichmondVirginia23249-
Research SiteWoodbridgeVirginia22192-
Research SiteSeattleWashington98195-

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