A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT03036150
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dapagliflozin — DRUG
    10 mg or 5 mg tablets given once daily, per oral use.
  • Placebo — DRUG
    Placebo matching dapagliflozin 10 mg or 5 mg

Study Details

The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and cardiovascular mortality in patients with chronic kidney disease.

Key Dates

Start date
Feb 2, 2017
Status verified
Jun 2021
Primary completion
Jun 12, 2020
Completion
Jun 12, 2020

Study Design

Enrollment
4,304 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    Patients will be randomized 1:1 to either dapagliflozin or placebo.
  • Placebo Comparator: Placebo
    Placebo matching dapagliflozin.

Primary Outcome Measure

Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death. [ Time Frame: Up to 38.2 months ]

Locations (55)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35233-
Research SiteHawaiian GardensCalifornia90716-
Research SiteLomitaCalifornia90717-
Research SiteLos AngelesCalifornia90022-
Research SitePalo AltoCalifornia94304-
Research SiteSan DimasCalifornia91773-
Research SiteSan RamonCalifornia94582-
Research SiteVistaCalifornia92083-
Research SiteAuroraColorado80045-
Research SiteDenverColorado80246-
Research SiteBoynton BeachFlorida33435-
Research SiteBoynton BeachFlorida33472-
Research SiteJacksonvilleFlorida32224-
Research SiteMiamiFlorida33015-
Research SiteMiamiFlorida33144-
Research SiteMiamiFlorida33165-
Research SiteMiami LakesFlorida33014-
Research SiteNaplesFlorida34102-
Research SiteNew Port RicheyFlorida34652-
Research SiteAtlantaGeorgia30342-1797-
Research SiteAugustaGeorgia30904-
Research SiteChicagoIllinois60643-
Research SiteIowa CityIowa52242-
Research SiteTopekaKansas66606-
Research SiteWichitaKansas67214-
Research SiteMetairieLouisiana70006-
Research SiteBostonMassachusetts02111-
Research SiteDetroitMichigan48202-
Research SiteFlintMichigan48504-
Research SiteDuluthMinnesota55805-
Research SiteOmahaNebraska68105-
Research SiteAlbanyNew York12208-
Research SiteAshevilleNorth Carolina28801-
Research SiteCharlotteNorth Carolina28207-
Research SiteHickoryNorth Carolina28601-
Research SiteNew BernNorth Carolina28562-
Research SiteWinston-SalemNorth Carolina27103-
Research SiteCincinnatiOhio45219-
Research SiteMaumeeOhio43537-
Research SiteJersey ShorePennsylvania17740-
Research SitePhiladelphiaPennsylvania19104-
Research SiteGreerSouth Carolina29651-
Research SiteKingsportTennessee37660-
Research SiteNashvilleTennessee37232-
Research SiteEl PasoTexas79935-
Research SiteFort WorthTexas76116-
Research SiteFort WorthTexas76117-
Research SiteFort WorthTexas76164-
Research SiteHoustonTexas77004-
Research SiteHoustonTexas77030-
Research SiteOdessaTexas79761-
Research SiteBurkeVirginia22015-
Research SiteManassasVirginia20110-
Research SiteNewport NewsVirginia23606-
Research SiteTacomaWashington98405-

Find similar trials in Birmingham, AL

By condition
Chronic kidney disease
By specialty
NephrologyKidney disease
By research site
Research Site· Birmingham, ALResearch Site· Hawaiian Gardens, CAResearch Site· Lomita, CAResearch Site· Los Angeles, CAResearch Site· Palo Alto, CAResearch Site· San Dimas, CA

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