Clinical trial NCT02942407: Trial to Evaluate Anticoagulation Therapy in Hemodialysis Patients With Atrial Fibrillation
Official title: RENal Hemodialysis Patients ALlocated Apixaban Versus Warfarin in Atrial Fibrillation (RENAL-AF) Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
End Stage Renal Disease
Keywords: Renal dialysis
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2016-10-24
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized, open-label, blinded end-point evaluation trial. The patient population consists of patients on hemodialysis who have atrial fibrillation (AF) and end-stage renal disease (ESRD) .

Detailed description: This is a multicenter study in adult patients with AF and ESRD who are on hemodialysis and who have stroke risk factors making them candidates for oral anticoagulation. Patients will be randomized to apixaban versus warfarin, and will be treated for up to 15 months.

Eligibility criteria: Inclusion Criteria:

* Males and females, age at least 18 years, or the local age of consent, whichever is greater.
* Patients with AF defined as AF on ECG at enrollment or two or more reports of AF from separate monitoring events at least 2 weeks apart (report of ECG, Holter monitor, event monitor or implantable loop recorder).
* CHA2DS2-VASc score of ≥ 2.
* End-stage renal disease treated with hemodialysis for ≥ 3 months.
* Considered by the treating physician(s) to be candidate for oral anticoagulation.
* If of childbearing potential, be willing to avoid pregnancy during the study.

Exclusion Criteria:

* Not considered by the treating physician(s) to be candidates for oral anticoagulation (for example, hemoglobin \< 8.5g/dL, history of intracranial hemorrhage, active bleeding, recent gastrointestinal bleed or retroperitoneal bleed, severe hepatic impairment, or anaphylactic reaction to apixaban)
* Moderate or severe mitral stenosis
* Conditions other than AF that require anticoagulation such as mechanical prosthetic valve, deep venous thrombosis, or pulmonary embolism
* Need for aspirin at a dose \> 81 mg a day or need for P2Y12 antagonist therapy (for example clopidogrel, prasugrel, or ticagrelor)
* Life expectancy \< 3 months
* Anticipated kidney transplant within the next 3 months
* Prisoners or others who are involuntarily incarcerated or detained
* Pregnant, breastfeeding, or considering pregnancy.
* Participation in a clinical trial of an experimental treatment within the past 30 days

Primary outcomes:
measure: Number of Participants Experiencing ISTH (International Society on Thrombosis and Haemostasis) Major or Clinically Relevant Non-major Bleeding
timeFrame: Randomization up to Month 15/Final Visit
Secondary outcomes:
measure: Number of Participants Experiencing Stroke or Systemic Embolism
timeFrame: Randomization up to Month 15/Final Visit
measure: Number of Participants Experiencing Mortality
timeFrame: Randomization up to Month 15/Final Visit
measure: Persistence of Therapy
timeFrame: Randomization up to Month 15/Final Visit
measure: Apixaban Plasma Concentration, Cmax
timeFrame: 0-12 hours post-dose
measure: Apixaban Plasma Concentration, Cmin
timeFrame: 0-12 hours post-dose
measure: Area Under the Plasma Apixaban Concentration Curve From 0 to 12 Hours After Dose (AUCO-12)
timeFrame: 0-12 hours post-dose
measure: Apixaban Pharmacodynamics, Chromogenic Factor Xa Assay
timeFrame: Baseline: Day 3, 4, or 5; Day 28
measure: Adherence to Treatment With Apixaban or With Warfarin
timeFrame: Month 15/Final Visit
Other outcomes:
measure: Number of Participants Experiencing Systemic Embolism
timeFrame: Randomization up to Month 15/Final Visit
measure: Number of Participants Experiencing Stroke
timeFrame: Randomization up to Month 15/Final Visit
measure: Number of Participants Experiencing Stroke, Systemic Embolism, Major Bleeding or All-cause Mortality
timeFrame: Randomization up to Month 15/Final Visit
measure: Baseline Biomarkers
timeFrame: Baseline
Locations:
city: Huntsville
country: United States
facility: Nephrology Consultants
state: Alabama
city: Fresno
country: United States
facility: The Medical Research Group, Inc.
state: California
city: Long Beach
country: United States
facility: DaVita Clinical Trials, LLC
state: California
city: Long Beach
country: United States
facility: Southland Renal Medical Group
state: California
city: Northridge
country: United States
facility: Valley Renal Medical Group Research
state: California
city: Roseville
country: United States
facility: Summit Nephrology Medical Group, Inc.
state: California
city: San Jose
country: United States
facility: Satellite Healthcare
state: California
city: Washington
country: United States
facility: Washington Nephrology Associates
state: District of Columbia
city: Coral Springs
country: United States
facility: South Florida Nephrology Group PA, Research Division
state: Florida
city: Miami
country: United States
facility: LG. Diagnostic, Inc. & Cosmetic Center
state: Florida
city: Miami
country: United States
facility: Nuren Medical and Research Center
state: Florida
city: Miami
country: United States
facility: Medical Professional Clinical Research Center
state: Florida
city: Meridian
country: United States
facility: Boise Kidney and Hypertension Institute
state: Idaho
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Crystal Lake
country: United States
facility: NANI Research
state: Illinois
city: River Forest
country: United States
facility: NANI Research
state: Illinois
city: Fort Wayne
country: United States
facility: NANI Research
state: Indiana
city: Shreveport
country: United States
facility: Northwest Louisiana Nephrology
state: Louisiana
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
city: Baltimore
country: United States
facility: The Johns Hopkins University
state: Maryland
city: Takoma Park
country: United States
facility: Washington Nephrology Associates
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Plymouth
country: United States
facility: South Shore Nephrology
state: Massachusetts
city: Springfield
country: United States
facility: Renal and Transplant Associates of New England
state: Massachusetts
city: Kalamazoo
country: United States
facility: Paragon Health Neprhology Centre
state: Michigan
city: Port Huron
country: United States
facility: St. Clair Nephrology
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Brookhaven
country: United States
facility: Southwest Mississippi Nephrology, PLLC
state: Mississippi
city: Gulfport
country: United States
facility: Southern Clinical Research Group, LLC
state: Mississippi
city: Tupelo
country: United States
facility: Nephrology & Hypertension Associates
state: Mississippi
city: Saint Louis
country: United States
facility: Polack Renal, LLC
state: Missouri
city: Reno
country: United States
facility: Sierra Nevada Nephrology Consultants
state: Nevada
city: Albuquerque
country: United States
facility: Renal Medicine Associates
state: New Mexico
city: Poughkeepsie
country: United States
facility: Advanced Kidney Care of Hudson Valley
state: New York
city: Durham
country: United States
facility: Durham Nephrology Associates
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Kinston
country: United States
facility: Eastern Nephrology Associates, PLLC.
state: North Carolina
city: New Bern
country: United States
facility: Eastern Nephrology Associates, PLLC
state: North Carolina
city: Columbus
country: United States
facility: HNC Dialysis, Ltd.
state: Ohio
city: Bethlehem
country: United States
facility: Northeast Clinical Research Ctr
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Health - Milton S. Hershey Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Columbia
country: United States
facility: Columbia Nephrology Associates
state: South Carolina
city: Orangeburg
country: United States
facility: South Carolina Nephrology and Hypertension
state: South Carolina
city: Sumter
country: United States
facility: Sumter Medical Specialists
state: South Carolina
city: Rapid City
country: United States
facility: Regional Health Clinical Research
state: South Dakota
city: Knoxville
country: United States
facility: Knoxville Kidney Center
state: Tennessee
city: Houston
country: United States
facility: Southwest Houston Research, Ltd.
state: Texas
city: Lubbock
country: United States
facility: Lubbock Vascular Access Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Alexandria
country: United States
facility: Washington Nephrology Associates
state: Virginia
city: Charlottesville
country: United States
facility: University of Virgina Health System
state: Virginia
city: Newport News
country: United States
facility: TPMG Clinical Research
state: Virginia
city: Roanoke
country: United States
facility: Valley Nephrology Associates
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Bluefield
country: United States
facility: Nephrology and Hypertension Associates
state: West Virginia
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Wausau
country: United States
facility: Aspirius Research Institute
state: Wisconsin
Study officials:
affiliation: Duke University
name: Christopher Granger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Glenn Chertow, MD
role: PRINCIPAL_INVESTIGATOR
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