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Trial to Evaluate Anticoagulation Therapy in Hemodialysis Patients With Atrial Fibrillation (RENAL-AF)

Primary Purpose

Atrial Fibrillation, End Stage Renal Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
apixaban
warfarin
Sponsored by
Christopher Granger, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Renal dialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nephrology Consultants
  • The Medical Research Group, Inc.
  • DaVita Clinical Trials, LLC
  • Southland Renal Medical Group
  • Valley Renal Medical Group Research
  • Summit Nephrology Medical Group, Inc.
  • Satellite Healthcare
  • Washington Nephrology Associates
  • South Florida Nephrology Group PA, Research Division
  • LG. Diagnostic, Inc. & Cosmetic Center
  • Nuren Medical and Research Center
  • Medical Professional Clinical Research Center
  • Boise Kidney and Hypertension Institute
  • Northwestern University
  • NANI Research
  • NANI Research
  • NANI Research
  • Northwest Louisiana Nephrology
  • Anne Arundel Medical Center
  • The Johns Hopkins University
  • Washington Nephrology Associates
  • Massachusetts General Hospital
  • South Shore Nephrology
  • Renal and Transplant Associates of New England
  • Paragon Health Neprhology Centre
  • St. Clair Nephrology
  • Mayo Clinic
  • Southwest Mississippi Nephrology, PLLC
  • Southern Clinical Research Group, LLC
  • Nephrology & Hypertension Associates
  • Polack Renal, LLC
  • Sierra Nevada Nephrology Consultants
  • Renal Medicine Associates
  • Advanced Kidney Care of Hudson Valley
  • Durham Nephrology Associates
  • East Carolina University
  • Eastern Nephrology Associates, PLLC.
  • Eastern Nephrology Associates, PLLC
  • HNC Dialysis, Ltd.
  • Northeast Clinical Research Ctr
  • Penn State Health - Milton S. Hershey Medical Center
  • Rhode Island Hospital
  • Columbia Nephrology Associates
  • South Carolina Nephrology and Hypertension
  • Sumter Medical Specialists
  • Regional Health Clinical Research
  • Knoxville Kidney Center
  • Southwest Houston Research, Ltd.
  • Lubbock Vascular Access Center
  • University of Utah
  • Washington Nephrology Associates
  • University of Virgina Health System
  • TPMG Clinical Research
  • Valley Nephrology Associates
  • University of Washington
  • Nephrology and Hypertension Associates
  • West Virginia University
  • Aspirius Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

apixaban

warfarin

Arm Description

apixaban 5 mg twice daily (apixaban 2.5 mg twice daily for selected patients)

warfarin daily dose adjusted to target International Normalized Ration(INR) of 2-3

Outcomes

Primary Outcome Measures

Number of Participants Experiencing ISTH (International Society on Thrombosis and Haemostasis) Major or Clinically Relevant Non-major Bleeding
Assess the safety of apixaban versus warfarin regarding ISTH major bleeding or clinically relevant non-major bleeding events in patients with NVAF (nonvalvular atrial fibrillation) and ESRD (end-stage renal disease) on hemodialysis. Major bleeding event is defined as:Acute clinically overt bleeding (including access site related bleeding) accompanied by 1 or more of the following: Decrease in Hgb of 2g/dL or more with overt bleeding; Transfusion of 2 or more units of packed RBCs in the setting of an overt bleeding event; Bleeding within a critical site. Hemorrhagic stroke (primary or infarction with hemorrhagic conversion) were classified as major bleeds. Non-major bleeding event is defined as: Acute or sub-acute clinically overt bleeding (including access site related bleeding) that does not meet criteria for major bleeding & results in Hospital admission for bleeding, physician guided medical or surgical treatment for bleeding, or change in antithrombotic therapy

Secondary Outcome Measures

Number of Participants Experiencing Stroke or Systemic Embolism
Number of participants experiencing adjudicated stroke or systemic embolism.
Number of Participants Experiencing Mortality
Evaluate mortality rates for those participants randomized to warfarin and apixaban in patients with NVAF and ESRD on hemodialysis
Persistence of Therapy
Evaluate days between time from initiation to discontinuation of randomized therapy.
Apixaban Plasma Concentration, Cmax
Evaluate the pharmacokinetics of apixaban in ESRD NVAF patients on hemodialysis. The measurement was done from 0-12 hours after the dose was given on Day 1.
Apixaban Plasma Concentration, Cmin
Evaluate the pharmacokinetics of apixaban in ESRD NVAF patients on hemodialysis. The measurement was done from 0-12 hours after the dose was given on Day 1.
Area Under the Plasma Apixaban Concentration Curve From 0 to 12 Hours After Dose (AUCO-12)
Evaluate the pharmacokinetics of apixaban in ESRD NVAF patients on hemodialysis. The measurement was done from 0 to 12 hours after dose was given on Day 1.
Apixaban Pharmacodynamics, Chromogenic Factor Xa Assay
Evaluate the pharmacodynamics of apixaban in ESRD NVAF patients on hemodialysis
Adherence to Treatment With Apixaban or With Warfarin
Measured by self-reported days of medication compliance over the last 30 days.

Full Information

First Posted
April 14, 2016
Last Updated
December 2, 2020
Sponsor
Christopher Granger, MD
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02942407
Brief Title
Trial to Evaluate Anticoagulation Therapy in Hemodialysis Patients With Atrial Fibrillation
Acronym
RENAL-AF
Official Title
RENal Hemodialysis Patients ALlocated Apixaban Versus Warfarin in Atrial Fibrillation (RENAL-AF) Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
July 27, 2019 (Actual)
Study Completion Date
August 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christopher Granger, MD
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, End Stage Renal Disease
Keywords
Renal dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
apixaban
Arm Type
Experimental
Arm Description
apixaban 5 mg twice daily (apixaban 2.5 mg twice daily for selected patients)
Arm Title
warfarin
Arm Type
Experimental
Arm Description
warfarin daily dose adjusted to target International Normalized Ration(INR) of 2-3
Intervention Type
Drug
Intervention Name(s)
apixaban
Other Intervention Name(s)
Eliquis
Intervention Description
oral anticoagulant
Intervention Type
Drug
Intervention Name(s)
warfarin
Other Intervention Name(s)
Coumadin, Jantoven
Intervention Description
oral anticoagulant
Primary Outcome Measure Information:
Title
Number of Participants Experiencing ISTH (International Society on Thrombosis and Haemostasis) Major or Clinically Relevant Non-major Bleeding
Description
Assess the safety of apixaban versus warfarin regarding ISTH major bleeding or clinically relevant non-major bleeding events in patients with NVAF (nonvalvular atrial fibrillation) and ESRD (end-stage renal disease) on hemodialysis. Major bleeding event is defined as:Acute clinically overt bleeding (including access site related bleeding) accompanied by 1 or more of the following: Decrease in Hgb of 2g/dL or more with overt bleeding; Transfusion of 2 or more units of packed RBCs in the setting of an overt bleeding event; Bleeding within a critical site. Hemorrhagic stroke (primary or infarction with hemorrhagic conversion) were classified as major bleeds. Non-major bleeding event is defined as: Acute or sub-acute clinically overt bleeding (including access site related bleeding) that does not meet criteria for major bleeding & results in Hospital admission for bleeding, physician guided medical or surgical treatment for bleeding, or change in antithrombotic therapy
Time Frame
Randomization up to Month 15/Final Visit
Secondary Outcome Measure Information:
Title
Number of Participants Experiencing Stroke or Systemic Embolism
Description
Number of participants experiencing adjudicated stroke or systemic embolism.
Time Frame
Randomization up to Month 15/Final Visit
Title
Number of Participants Experiencing Mortality
Description
Evaluate mortality rates for those participants randomized to warfarin and apixaban in patients with NVAF and ESRD on hemodialysis
Time Frame
Randomization up to Month 15/Final Visit
Title
Persistence of Therapy
Description
Evaluate days between time from initiation to discontinuation of randomized therapy.
Time Frame
Randomization up to Month 15/Final Visit
Title
Apixaban Plasma Concentration, Cmax
Description
Evaluate the pharmacokinetics of apixaban in ESRD NVAF patients on hemodialysis. The measurement was done from 0-12 hours after the dose was given on Day 1.
Time Frame
0-12 hours post-dose
Title
Apixaban Plasma Concentration, Cmin
Description
Evaluate the pharmacokinetics of apixaban in ESRD NVAF patients on hemodialysis. The measurement was done from 0-12 hours after the dose was given on Day 1.
Time Frame
0-12 hours post-dose
Title
Area Under the Plasma Apixaban Concentration Curve From 0 to 12 Hours After Dose (AUCO-12)
Description
Evaluate the pharmacokinetics of apixaban in ESRD NVAF patients on hemodialysis. The measurement was done from 0 to 12 hours after dose was given on Day 1.
Time Frame
0-12 hours post-dose
Title
Apixaban Pharmacodynamics, Chromogenic Factor Xa Assay
Description
Evaluate the pharmacodynamics of apixaban in ESRD NVAF patients on hemodialysis
Time Frame
Baseline: Day 3, 4, or 5; Day 28
Title
Adherence to Treatment With Apixaban or With Warfarin
Description
Measured by self-reported days of medication compliance over the last 30 days.
Time Frame
Month 15/Final Visit
Other Pre-specified Outcome Measures:
Title
Number of Participants Experiencing Systemic Embolism
Description
Adjudicated diagnosis of systemic arterial embolism (Non-pulmonary, non-cranial events) will require a positive clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), which is supported by evidence of embolism/thrombosis from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing. Clinical presentation would include: Abrupt development of pain, absent pulses, pallor, and/or paresis in an extremity (at least an entire digit) without previous severe claudication or findings of severe peripheral vascular disease. Renal embolism will be diagnosed when sudden flank pain or a change in renal laboratory findings occurred. Abdominal vascular/visceral embolism was considered definite if acute abdominal symptoms or referred symptoms developed along with a change in abdominal examination or appropriate laboratory values.
Time Frame
Randomization up to Month 15/Final Visit
Title
Number of Participants Experiencing Stroke
Description
Adjudcated stroke defined as a new, non-traumatic episode of focal or global neurological dysfunction of sudden onset caused by central nervous system (CNS) vascular injury as a result of hemorrhage or infarction and not due to a readily identifiable non-vascular cause (i.e. brain tumor). CNS includes brain, spinal cord and retina. The required duration of the deficit is ≥ 24 hours. Events with neurologic deficit lasting for < 24 hours and an imaging modality showing evidence of an acute stroke will be counted as stroke as well. A retinal ischemic event (embolism, infarction) will be considered a stroke
Time Frame
Randomization up to Month 15/Final Visit
Title
Number of Participants Experiencing Stroke, Systemic Embolism, Major Bleeding or All-cause Mortality
Description
Evaluate those experiencing stroke, systemic embolism, ISTH major bleeding, or all-cause mortality for those randomized to warfarin and apixaban in patients with NVAF and ESRD on hemodialysis Definitions of stroke and systemic embolism are provided under the measurement description of the secondary outcomes for each individual event. Definition of major bleed is provided in outcome measurement description of the primary outcome measure.
Time Frame
Randomization up to Month 15/Final Visit
Title
Baseline Biomarkers
Description
Analysis of outcomes and treatment effect according to levels of cardiovascular biomarkers at baseline
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Granger, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Glenn Chertow, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nephrology Consultants
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
The Medical Research Group, Inc.
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
DaVita Clinical Trials, LLC
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Southland Renal Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Valley Renal Medical Group Research
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Summit Nephrology Medical Group, Inc.
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Satellite Healthcare
City
San Jose
State/Province
California
ZIP/Postal Code
95126
Country
United States
Facility Name
Washington Nephrology Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
South Florida Nephrology Group PA, Research Division
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33071
Country
United States
Facility Name
LG. Diagnostic, Inc. & Cosmetic Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Nuren Medical and Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Medical Professional Clinical Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Boise Kidney and Hypertension Institute
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
NANI Research
City
Crystal Lake
State/Province
Illinois
ZIP/Postal Code
60014
Country
United States
Facility Name
NANI Research
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
Facility Name
NANI Research
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Northwest Louisiana Nephrology
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Anne Arundel Medical Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
The Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Washington Nephrology Associates
City
Takoma Park
State/Province
Maryland
ZIP/Postal Code
20912
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
South Shore Nephrology
City
Plymouth
State/Province
Massachusetts
ZIP/Postal Code
02360
Country
United States
Facility Name
Renal and Transplant Associates of New England
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Paragon Health Neprhology Centre
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
St. Clair Nephrology
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Southwest Mississippi Nephrology, PLLC
City
Brookhaven
State/Province
Mississippi
ZIP/Postal Code
39601
Country
United States
Facility Name
Southern Clinical Research Group, LLC
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39501
Country
United States
Facility Name
Nephrology & Hypertension Associates
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Polack Renal, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
Sierra Nevada Nephrology Consultants
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Renal Medicine Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Advanced Kidney Care of Hudson Valley
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Durham Nephrology Associates
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Eastern Nephrology Associates, PLLC.
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28504
Country
United States
Facility Name
Eastern Nephrology Associates, PLLC
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
HNC Dialysis, Ltd.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Northeast Clinical Research Ctr
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Penn State Health - Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Columbia Nephrology Associates
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
South Carolina Nephrology and Hypertension
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Sumter Medical Specialists
City
Sumter
State/Province
South Carolina
ZIP/Postal Code
29150
Country
United States
Facility Name
Regional Health Clinical Research
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Knoxville Kidney Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Facility Name
Southwest Houston Research, Ltd.
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Lubbock Vascular Access Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79416
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Washington Nephrology Associates
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
Facility Name
University of Virgina Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
TPMG Clinical Research
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Valley Nephrology Associates
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Nephrology and Hypertension Associates
City
Bluefield
State/Province
West Virginia
ZIP/Postal Code
24701
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Aspirius Research Institute
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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20054291
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United States Renal Data System Web Site

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Trial to Evaluate Anticoagulation Therapy in Hemodialysis Patients With Atrial Fibrillation

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