A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure.

Part of paid clinical trials in Fairhope, Alabama.

Sponsor
AstraZeneca
Study ID
NCT06268873
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Chronic Kidney Disease and Hypertension

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin in participants ≥ 18 years of age with CKD and HTN. This study consists of a screening, a 4-week dapagliflozin run-in period for participants untreated with SGLT2i at baseline; a 24-month double-blind period in which participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin; and approximately 12-week open-label period in which all participants will discontinue baxdrostat/placebo and receive dapagliflozin alone. Site visits will take place at 2-, 4-, 8-, and 16- weeks following randomisation. Thereafter visits will occur approximately every 4 months, until the 24-month visit at which time baxdrostat/placebo will be discontinued. Participants will continue open-label dapagliflozin for another 12-weeks (approximately), where reassessment of eGFR will occur for the primary efficacy endpoint. In the event of premature discontinuation of blinded study intervention, participants will continue in the study and receive open-label dapagliflozin monotherapy, unless the participant meets dapagliflozin specific discontinuation criteria, in which case all study interventions will be discontinued.

Key Dates

Start date
Mar 29, 2024
Status verified
May 2026
Primary completion
Feb 24, 2028
Completion
Feb 24, 2028

Study Design

Enrollment
2,554 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone to slow CKD progression, assessed as the effect on change in eGFR over time. [ Time Frame: Baseline - 2 years + 12 weeks ]

Locations (114)

FacilityCityStateZIPSite coordinators
Research SiteFairhopeAlabama36532-
Research SitePhoenixArizona85016-
Research SiteSurpriseArizona85374-
Research SiteTucsonArizona85710-
Research SiteSearcyArkansas72143-
Research SiteBeverly HillsCalifornia90211-
Research SiteCanyon CountryCalifornia91351-
Research SiteFremontCalifornia94538-
Research SiteFullertonCalifornia92835-
Research SiteLincolnCalifornia95648-
Research SiteLos AlamitosCalifornia90720-
Research SiteSan FranciscoCalifornia94110-
Research SiteStanfordCalifornia94305-
Research SiteTarzanaCalifornia91356-
Research SiteArvadaColorado80002-
Research SiteDenverColorado80220-
Research SiteNew BritainConnecticut06051-
Research SiteBoca RatonFlorida33487-
Research SiteBoynton BeachFlorida33435-
Research SiteEdgewaterFlorida32132-
Research SiteFort LauderdaleFlorida33316-
Research SiteHialeahFlorida33012-
Research SiteHollywoodFlorida33021-
Research SiteJacksonvilleFlorida32204-
Research SiteJacksonville BeachFlorida32250-
Research SiteLake CityFlorida32055-
Research SiteLake WorthFlorida33467-
Research SiteMelbourneFlorida32901-
Research SiteMiamiFlorida33165-
Research SiteMiami LakesFlorida33014-
Research SiteNew Port RicheyFlorida34652-
Research SiteOcoeeFlorida34761-
Research SiteOrlandoFlorida32806-
Research SiteOrlandoFlorida32808-
Research SitePort CharlotteFlorida33952-
Research SitePort OrangeFlorida32127-
Research SiteRiverviewFlorida33578-
Research SiteWinter HavenFlorida33880-
Research SiteAtlantaGeorgia30344-
Research SiteConyersGeorgia30094-
Research SiteMaconGeorgia31210-
Research SiteChampaignIllinois61822-
Research SiteHazel CrestIllinois60429-
Research SiteHuntleyIllinois60142-
Research SiteRockfordIllinois61107-
Research SiteEvansvilleIndiana47714-
Research SiteFort WayneIndiana46804-
Research SiteHutchinsonKansas67502-
Research SiteWichitaKansas67214-
Research SiteBethesdaMaryland20889-
Research SiteLanhamMaryland20706-
Research SiteBostonMassachusetts02114-
Research SiteBostonMassachusetts02115-
Research SiteNew BedfordMassachusetts02740-
Research SiteDetroitMichigan48202-
Research SitePontiacMichigan48341-
Research SiteSaint JosephMichigan49085-
Research SiteCity of Saint PetersMissouri63376-
Research SiteKansas CityMissouri64111-
Research SiteKansas CityMissouri64128-
Research SiteKansas CityMissouri64151-
Research SiteSt LouisMissouri63136-
Research SiteEatontownNew Jersey07724-
Research SiteBinghamtonNew York13905-
Research SiteManhassetNew York11030-
Research SiteMiddletownNew York10940-
Research SiteNew YorkNew York10016-
Research SiteNiagara FallsNew York14304-
Research SiteOrchard ParkNew York14127-
Research SiteRockville CentreNew York11570-
Research SiteGreenvilleNorth Carolina27834-
Research SiteJacksonvilleNorth Carolina28546-
Research SiteNew BernNorth Carolina28562-
Research SiteStatesvilleNorth Carolina28625-
Research SiteWilmingtonNorth Carolina28401-
Research SiteWilmingtonNorth Carolina28412-
Research SiteColumbusOhio43213-
Research SiteColumbusOhio43215-
Research SiteMaumeeOhio43537-
Research SiteChesterPennsylvania19013-
Research SiteLanghornePennsylvania19047-
Research SiteUniontownPennsylvania15401-
Research SiteEast ProvidenceRhode Island02914-
Research SiteEast ProvidenceRhode Island02915-
Research SiteProvidenceRhode Island02904-
Research SiteCharlestonSouth Carolina29414-
Research SiteColumbiaSouth Carolina29203-
Research SiteSioux FallsSouth Dakota57104-
Research SiteChattanoogaTennessee37421-
Research SiteMemphisTennessee38105-
Research SiteMemphisTennessee38115-
Research SiteArlingtonTexas76015-
Research SiteAustinTexas78726-
Research SiteAustinTexas78751-
Research SiteDallasTexas75230-
Research SiteDallasTexas75246-
Research SiteHoustonTexas77004-
Research SiteHoustonTexas77040-
Research SiteHoustonTexas77084-
Research SiteHoustonTexas77099-
Research SiteHumbleTexas77338-
Research SiteLewisvilleTexas75057-
Research SiteOdessaTexas79761-
Research SitePasadenaTexas77504-
Research SiteSan AntonioTexas78212-
Research SiteSan AntonioTexas78231-
Research SiteSalt Lake CityUtah84132-
Research SiteSouth Salt LakeUtah84115-
Research SiteBurlingtonVermont05401-
Research SiteArlingtonVirginia22205-
Research SiteManassasVirginia20110-
Research SiteNewport NewsVirginia23606-
Research SiteSalemVirginia24153-
Research SiteWoodbridgeVirginia22192-

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