Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin in Participants With Chronic Kidney Disease and High Proteinuria (ZENITH High Proteinuria)

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
AstraZeneca
Study ID
NCT06087835
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Chronic Kidney Disease With High Proteinuria

Eligibility Criteria

Sex
ALL
Age
18 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

  • Zibotentan/Dapagliflozin — DRUG
    Participants will receive zibotentan/dapagliflozin in fixed-dose combination as per the arms they are randomized to
  • Dapagliflozin — DRUG
    Participants will receive dapagliflozin as per the arms they are randomized to

Study Details

This is a Phase III, randomised, multicentre, double-blinded study to evaluate efficacy, safety and tolerability of treatment with zibotentan/dapagliflozin and dapagliflozin alone in participants with chronic kidney disease (CKD) and high proteinuria

Key Dates

Start date
Nov 7, 2023
Status verified
May 2026
Primary completion
Feb 18, 2027
Completion
Feb 18, 2027

Study Design

Enrollment
1,835 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Zibotentan/Dapagliflozin dose A or Zibotentan/Dapagliflozin dose B
    Drug dose (dose A or B) are determined based on eGFR values. Participants will receive daily oral dose of zibotentan/dapagliflozin in fixed dose combination.
  • Active Comparator: Dapagliflozin alone
    Participants will receive daily oral dose of dapagliflozin.

Primary Outcome Measure

Change in eGFR from baseline [ Time Frame: At month 24 ]

Locations (64)

FacilityCityStateZIPSite coordinators
Research SiteHuntsvilleAlabama35805-
Research SiteSun City WestArizona85375-
Research SiteBakersfieldCalifornia93309-
Research SiteHuntington ParkCalifornia90255-
Research SiteLos AlamitosCalifornia90720-
Research SiteLos AngelesCalifornia90010-
Research SiteNorthridgeCalifornia91324-
Research SiteOxnardCalifornia93036-
Research SiteSan CarlosCalifornia94070-
Research SiteSan DimasCalifornia91773-
Research SiteTarzanaCalifornia91356-
Research SiteVictorvilleCalifornia92392-
Research SiteArvadaColorado80002-
Research SiteDenverColorado80230-
Research SiteBoynton BeachFlorida33435-
Research SiteHialeahFlorida33016-
Research SiteHollywoodFlorida33024-
Research SiteJacksonvilleFlorida32204-
Research SiteJensen BeachFlorida34957-
Research SiteMiamiFlorida33126-
Research SiteMiamiFlorida33165-
Research SiteOrlandoFlorida32806-
Research SiteFayettevilleGeorgia30214-
Research SiteChampaignIllinois61822-
Research SiteChicagoIllinois60616-
Research SiteHinsdaleIllinois60521-
Research SiteIsland LakeIllinois60042-
Research SiteSkokieIllinois60077-
Research SiteBowling GreenKentucky42101-
Research SiteShreveportLouisiana71101-
Research SiteSilver SpringMaryland20901-
Research SiteFlintMichigan48504-
Research SiteFlintMichigan48532-
Research SiteTroyMichigan48098-
Research SiteCity of Saint PetersMissouri63376-
Research SiteAlbanyNew York12205-
Research SiteMiddletownNew York10940-
Research SiteOrchard ParkNew York14127-
Research SiteGreenvilleNorth Carolina27834-
Research SiteJacksonvilleNorth Carolina28546-
Research SiteKinstonNorth Carolina28504-
Research SiteNew BernNorth Carolina28562-
Research SiteStatesvilleNorth Carolina28625-
Research SiteWilmingtonNorth Carolina28401-
Research SiteWilmingtonNorth Carolina28412-
Research SiteWinston-SalemNorth Carolina27103-
Research SiteMaumeeOhio43537-
Research SitePottstownPennsylvania19464-
Research SiteEast ProvidenceRhode Island02915-
Research SiteKingsportTennessee37660-
Research SiteArlingtonTexas76015-
Research SiteAustinTexas78726-
Research SiteHoustonTexas77004-
Research SiteHoustonTexas77099-
Research SitePearlandTexas77584-
Research SiteSan AntonioTexas78204-
Research SiteSan AntonioTexas78207-
Research SiteSan AntonioTexas78212-
Research SiteSugar LandTexas77478-
Research SiteSouth Salt LakeUtah84115-
Research SiteAlexandriaVirginia22311-
Research SiteNewport NewsVirginia23606-
Research SiteMukilteoWashington98275-
Research SiteSpokaneWashington99202-

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