Zibotentan and Dapagliflozin for the Treatment of CKD (ZENITH-CKD Trial)

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
AstraZeneca
Study ID
NCT04724837
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Zibotentan — DRUG
    Participants will receive zibotentan as per the arms they are randomized.
  • Dapagliflozin — DRUG
    Participants will receive 10 mg dapagliflozin as per the arms they are randomized.
  • Placebo — DRUG
    Participants will receive placebo as per the arms they are randomized to.

Study Details

The purpose of the study is to assess efficacy, safety and tolerability of treatment with zibotentan and dapagliflozin in combination and dapagliflozin 10 mg as monotherapy in participants with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73 m\^2, and urinary albumin to creatinine ratio (UACR) ≥ 150 mg/g and ≤ 5000 mg/g.

Key Dates

Start date
Apr 28, 2021
Status verified
Jul 2024
Primary completion
Jun 1, 2023
Completion
Jun 1, 2023

Study Design

Enrollment
542 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Zibotentan Dose A + Dapagliflozin
    Participants will receive once daily oral dose A of zibotentan and 10 mg dapagliflozin for 12 weeks.
  • Experimental: Zibotentan Dose B + Dapagliflozin
    Participants will receive once daily oral dose B of zibotentan and 10 mg dapagliflozin for 12 weeks.
  • Experimental: Placebo + Dapagliflozin
    Participants will receive once daily oral dose of dapagliflozin 10 mg and placebo for 12 weeks.

Primary Outcome Measure

Change in Urinary Albumin to Creatinine Ratio (UACR) From Baseline to Week 12 [ Time Frame: From baseline (Week 0 [Day 1]) until Week 12 (Day 84) ]

Locations (50)

FacilityCityStateZIPSite coordinators
Research SiteHuntsvilleAlabama35805-
Research SiteBeverly HillsCalifornia90211-
Research SiteDowneyCalifornia90242-
Research SiteFountain ValleyCalifornia92708-
Research SiteLaguna HillsCalifornia92653-
Research SiteLos AngelesCalifornia90057-
Research SiteNorthridgeCalifornia91324-
Research SiteOntarioCalifornia91762-
Research SiteSouth GateCalifornia90280-
Research SiteTarzanaCalifornia91356-
Research SiteVacavilleCalifornia95687-
Research SiteFort LauderdaleFlorida33308-
Research SiteHialeahFlorida33012-
Research SiteNew Port RicheyFlorida34652-
Research SiteOrlandoFlorida32806-
Research SiteRiverviewFlorida33578-
Research SiteTampaFlorida33614-
Research SiteAugustaGeorgia30904-
Research SiteFayettevilleGeorgia30214-
Research SiteWichitaKansas67214-2943-
Research SiteOwensboroKentucky42303-
Research SiteMetairieLouisiana70006-
Research SiteShreveportLouisiana71101-
Research SiteBostonMassachusetts02215-
Research SiteFlintMichigan48504-
Research SiteFlintMichigan48532-
Research SiteLincolnNebraska68510-
Research SiteLas VegasNevada89128-
Research SiteGreenvilleNorth Carolina27834-
Research SiteJacksonvilleNorth Carolina28546-
Research SiteKinstonNorth Carolina28504-
Research SiteMorehead CityNorth Carolina28557-
Research SiteNew BernNorth Carolina28562-
Research SiteWilmingtonNorth Carolina28401-
Research SiteMarionOhio43302-
Research SiteChesterPennsylvania19013-
Research SiteMemphisTennessee38104-
Research SiteMemphisTennessee38119-
Research SiteArlingtonTexas76002-
Research SiteConroeTexas77384-
Research SiteCorpus ChristiTexas78414-
Research SiteEl PasoTexas79935-
Research SiteHoustonTexas77004-
Research SiteHoustonTexas77099-
Research SiteOdessaTexas79761-
Research SiteSan AntonioTexas78212-
Research SiteWaxahachieTexas75165-
Research SiteForestVirginia24551-
Research SiteNewport NewsVirginia23606-
Research SiteSpokaneWashington99204-

Find similar trials in Huntsville, AL

By condition
Chronic kidney disease
By specialty
NephrologyKidney disease
By research site
Research Site· Huntsville, ALResearch Site· Beverly Hills, CAResearch Site· Downey, CAResearch Site· Fountain Valley, CAResearch Site· Laguna Hills, CAResearch Site· Los Angeles, CA

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