EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Boehringer Ingelheim
Study ID
NCT03594110
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Empagliflozin — DRUG
    Taken daily with or without food
  • Matching placebo — DRUG
    Taken daily with or without food

Study Details

The primary aim of the study is to investigate the effect of empagliflozin on kidney disease progression or cardiovascular death versus placebo on top of standard of care in patients with pre-existing chronic kidney disease. After completion of the interventional part of the study (primary study completion) a subset of participants will be followed up in a post-trial observational (non-interventional) manner for cardio-renal outcomes (estimated study completion date).

Key Dates

Start date
Jan 31, 2019
Status verified
Jun 2025
Primary completion
Jul 5, 2022
Completion
Jul 2, 2024

Study Design

Enrollment
6,609 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Empagliflozin 10 mg
    Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily 10 milligram (mg) film-coated tablets of empagliflozin.
  • Placebo Comparator: Placebo
    Patients with evidence of chronic kidney disease (CKD) at risk of kidney disease progression, with or without diagnosed diabetes mellitus administered orally once daily film-coated tablets of placebo to match empagliflozin.

Primary Outcome Measure

Interventional Part: Time to First Occurrence of Kidney Disease Progression or Cardiovascular Death ('as Adjudicated') [ Time Frame: From the day of randomisation to the day of the final follow-up visit in the interventional part of the trial, up to 1136 days. ]

Locations (47)

FacilityCityStateZIPSite coordinators
Nephrology Consultants, LLCHuntsvilleAlabama35805-
Aventiv Research, IncMesaArizona85210-
Southern California Permanente Medical GroupSan DiegoCalifornia92123-
University of California Los AngelesSylmarCalifornia91342-
University of California Los AngelesTorranceCalifornia90502-
Yale University School of MedicineNew HavenConnecticut06510-
Chase Medical Research, LLCThomastonConnecticut06787-
Midland Florida Clinical Reearch Center, LLCDeLandFlorida32720-
University of FloridaGainesvilleFlorida32610-
East Coast Institute for Research, LLCJacksonvilleFlorida32216-
East Coast Clinical Research, IncLake CityFlorida32055-
Total Research Group, LLCMiamiFlorida33126-
Hanson Clinical Research Center, Inc.Port CharlotteFlorida33952-
Emory UniversityAtlantaGeorgia30322-
The Jones Center for Diabetes and Endocrine WellnessMaconGeorgia31210-
Cedar Crosse Research CenterChicagoIllinois60607-
Northwestern UniversityChicagoIllinois60611-
University of Kansas Medical CenterKansas CityKansas66160-
Saint Elizabeth HealthcareCovingtonKentucky41011-
Lexington VA Health Care System - Troy Bowling CampusLexingtonKentucky40502-
Medstar Health Research InstituteBaltimoreMaryland21239-
Kidney Care and Transplant Services of New England, PCWest SpringfieldMassachusetts01089-
Saint Clair Specialty PhysiciansRosevilleMichigan48066-
Clinical Research Consultants, LLCKansas CityMissouri64111-
VA Southern Nevada Healthcare SystemNorth Las VegasNevada89086-
Seacoast Kidney and Hypertension SpecialistsPortsmouthNew Hampshire03801-
SUNY Downstate Medical CenterBrooklynNew York11203-
Mountain Kidney and Hypertension Associates, PAAshevilleNorth Carolina28801-
The University of North Carolina at Chapel HillChapel HillNorth Carolina27514-
Brookview Hills Research Associates LLCWinston-SalemNorth Carolina27103-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
Cleveland ClinicClevelandOhio44195-
University Hospitals of ClevelandClevelandOhio44106-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19114-
Carolina Diabetes & Kidney CenterSumterSouth Carolina29150-
Regional Health Clinical ResearchRapid CitySouth Dakota57701-
Renal Disease Research InstituteDallasTexas75246-
Research Institute of DallasDallasTexas75231-
Academy Of Diabetes, Thyroid And Endocrine, PAEl PasoTexas79935-
Pioneer Research Solutions, Inc.HoustonTexas77099-
P&I Clinical Research, LLCLufkinTexas75904-
Texas Institute for Kidney and Endocrine DisordersLufkinTexas75904-
Clinical Advancement Center PLLCSan AntonioTexas78212-
University of Texas Health Science Center at San AntonioSan AntonioTexas78229-
University of Utah Health Sciences CenterSalt Lake CityUtah84108-
Salem VA Medical CenterSalemVirginia24153-
Providence Medical Research CenterSpokaneWashington99204-

Find similar trials in Huntsville, AL

By condition
Chronic kidney disease
By specialty
NephrologyKidney disease
By research site
Nephrology Consultants, LLC· Huntsville, ALAventiv Research, Inc· Mesa, AZSouthern California Permanente Medical Group· San Diego, CAUniversity of California Los Angeles· Sylmar, CAUniversity of California Los Angeles· Torrance, CAYale University School of Medicine· New Haven, CT

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