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Atrial FibrillationPhase 4RENAL-AFNCT02942407

Trial to Evaluate Anticoagulation Therapy in Hemodialysis Patients With Atrial Fibrillation

A Phase 4 study testing apixaban and warfarin in people with Atrial Fibrillation and End Stage Renal Disease, run by Christopher Granger, MD at 58 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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) . Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation, End Stage Renal Disease
What is being tested?
apixaban and warfarin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
58 sitesUnited States
Study dates
Dec 2016to 12 Aug 2019
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

58 sites in 1 country.

58 sites in 1 country

United States58 sites

  • Renal Medicine Associates

    Albuquerque, New Mexico, 87109

  • Washington Nephrology Associates

    Alexandria, Virginia, 22304

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • The Johns Hopkins University

    Baltimore, Maryland, 21224

  • Northeast Clinical Research Ctr

    Bethlehem, Pennsylvania, 18017

  • Nephrology and Hypertension Associates

    Bluefield, West Virginia, 24701

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Southwest Mississippi Nephrology, PLLC

    Brookhaven, Mississippi, 39601

  • University of Virgina Health System

    Charlottesville, Virginia, 22908

  • Northwestern University

    Chicago, Illinois, 60611

  • Columbia Nephrology Associates

    Columbia, South Carolina, 29203

  • HNC Dialysis, Ltd.

    Columbus, Ohio, 43215

  • South Florida Nephrology Group PA, Research Division

    Coral Springs, Florida, 33071

  • NANI Research

    Crystal Lake, Illinois, 60014

  • Durham Nephrology Associates

    Durham, North Carolina, 27704

  • NANI Research

    Fort Wayne, Indiana, 46804

  • The Medical Research Group, Inc.

    Fresno, California, 93720

  • East Carolina University

    Greenville, North Carolina, 27834

  • Southern Clinical Research Group, LLC

    Gulfport, Mississippi, 39501

  • Penn State Health - Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Southwest Houston Research, Ltd.

    Houston, Texas, 77099

  • Nephrology Consultants

    Huntsville, Alabama, 35805

  • Paragon Health Neprhology Centre

    Kalamazoo, Michigan, 49007

  • Eastern Nephrology Associates, PLLC.

    Kinston, North Carolina, 28504

  • Knoxville Kidney Center

    Knoxville, Tennessee, 37923

  • DaVita Clinical Trials, LLC

    Long Beach, California, 90806

  • Southland Renal Medical Group

    Long Beach, California, 90806

  • Lubbock Vascular Access Center

    Lubbock, Texas, 79416

  • Boise Kidney and Hypertension Institute

    Meridian, Idaho, 83642

  • LG. Diagnostic, Inc. & Cosmetic Center

    Miami, Florida, 33126

  • Nuren Medical and Research Center

    Miami, Florida, 33144

  • Medical Professional Clinical Research Center

    Miami, Florida, 33165

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Eastern Nephrology Associates, PLLC

    New Bern, North Carolina, 28562

  • TPMG Clinical Research

    Newport News, Virginia, 23606

  • Valley Renal Medical Group Research

    Northridge, California, 91324

  • South Carolina Nephrology and Hypertension

    Orangeburg, South Carolina, 29118

  • South Shore Nephrology

    Plymouth, Massachusetts, 02360

  • St. Clair Nephrology

    Port Huron, Michigan, 48060

  • Advanced Kidney Care of Hudson Valley

    Poughkeepsie, New York, 12601

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Regional Health Clinical Research

    Rapid City, South Dakota, 57701

  • Sierra Nevada Nephrology Consultants

    Reno, Nevada, 89511

  • NANI Research

    River Forest, Illinois, 60305

  • Valley Nephrology Associates

    Roanoke, Virginia, 24014

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Summit Nephrology Medical Group, Inc.

    Roseville, California, 95661

  • University of Utah

    Salt Lake City, Utah, 84112

  • Satellite Healthcare

    San Jose, California, 95126

  • University of Washington

    Seattle, Washington, 98104

  • Northwest Louisiana Nephrology

    Shreveport, Louisiana, 71101

  • Renal and Transplant Associates of New England

    Springfield, Massachusetts, 01107

  • Polack Renal, LLC

    St Louis, Missouri, 63136

  • Sumter Medical Specialists

    Sumter, South Carolina, 29150

  • Washington Nephrology Associates

    Takoma Park, Maryland, 20912

  • Nephrology & Hypertension Associates

    Tupelo, Mississippi, 38801

  • Washington Nephrology Associates

    Washington D.C., District of Columbia, 20010

  • Aspirius Research Institute

    Wausau, Wisconsin, 54401

Other trials in United States

About this study

Official title: RENal Hemodialysis Patients ALlocated Apixaban Versus Warfarin in Atrial Fibrillation (RENAL-AF) Randomized Clinical Trial

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) .

Read the 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.

Being tested
apixaban, warfarin
Keywords
Renal dialysis
Medical subject headings
Atrial Fibrillation, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • apixabanDrug

    Also called Eliquis

    oral anticoagulant

  • warfarinDrug

    Also called Coumadin, Jantoven

    oral anticoagulant

Study groups in NCT02942407
Study groupRoleWhat they receive
apixabanExperimentalapixaban 5 mg twice daily (apixaban 2.5 mg twice daily for selected patients)
Receives: Drug: apixaban
warfarinExperimentalwarfarin daily dose adjusted to target International Normalized Ration(INR) of 2-3
Receives: Drug: warfarin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Randomization up to Month 15/Final Visit

Secondary outcomes (8)

  1. Number of Participants Experiencing Stroke or Systemic Embolism

    Number of participants experiencing adjudicated stroke or systemic embolism.

    Measured: Randomization up to Month 15/Final Visit

  2. Number of Participants Experiencing Mortality

    Evaluate mortality rates for those participants randomized to warfarin and apixaban in patients with NVAF and ESRD on hemodialysis

    Measured: Randomization up to Month 15/Final Visit

  3. Persistence of Therapy

    Evaluate days between time from initiation to discontinuation of randomized therapy.

    Measured: Randomization up to Month 15/Final Visit

  4. 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.

    Measured: 0-12 hours post-dose

  5. 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.

    Measured: 0-12 hours post-dose

  6. 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.

    Measured: 0-12 hours post-dose

  7. Apixaban Pharmacodynamics, Chromogenic Factor Xa Assay

    Evaluate the pharmacodynamics of apixaban in ESRD NVAF patients on hemodialysis

    Measured: Baseline: Day 3, 4, or 5; Day 28

  8. Adherence to Treatment With Apixaban or With Warfarin

    Measured by self-reported days of medication compliance over the last 30 days.

    Measured: Month 15/Final Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2016 (estimated)
  2. Study startDec 2016
  3. Primary completion27 Jul 2019
  4. Study completion12 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02942407
Sponsor's protocol ID
Pro00068545
Acronym
RENAL-AF
Status last verified
Dec 2020
First submitted
14 Apr 2016
Last updated
29 Dec 2020
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Wizemann V, Tong L, Satayathum S, Disney A, Akiba T, Fissell RB, Kerr PG, Young EW, Robinson BM. Atrial fibrillation in hemodialysis patients: clinical features and associations with anticoagulant therapy. Kidney Int. 2010 Jun;77(12):1098-106. doi: 10.1038/ki.2009.477. Epub 2010 Jan 6.

    PubMed 20054291

  • Olesen JB, Lip GY, Kamper AL, Hommel K, Kober L, Lane DA, Lindhardsen J, Gislason GH, Torp-Pedersen C. Stroke and bleeding in atrial fibrillation with chronic kidney disease. N Engl J Med. 2012 Aug 16;367(7):625-35. doi: 10.1056/NEJMoa1105594.

    PubMed 22894575

  • Nigwekar SU, Bhan I, Turchin A, Skentzos SC, Hajhosseiny R, Steele D, Nazarian RM, Wenger J, Parikh S, Karumanchi A, Thadhani R. Statin use and calcific uremic arteriolopathy: a matched case-control study. Am J Nephrol. 2013;37(4):325-32. doi: 10.1159/000348806. Epub 2013 Mar 21.

    PubMed 23548843

  • Yang F, Chou D, Schweitzer P, Hanon S. Warfarin in haemodialysis patients with atrial fibrillation: what benefit? Europace. 2010 Dec;12(12):1666-72. doi: 10.1093/europace/euq387. Epub 2010 Nov 2.

    PubMed 21045011

  • Chan KE, Lazarus JM, Thadhani R, Hakim RM. Warfarin use associates with increased risk for stroke in hemodialysis patients with atrial fibrillation. J Am Soc Nephrol. 2009 Oct;20(10):2223-33. doi: 10.1681/ASN.2009030319. Epub 2009 Aug 27.

    PubMed 19713308

  • Shah M, Avgil Tsadok M, Jackevicius CA, Essebag V, Eisenberg MJ, Rahme E, Humphries KH, Tu JV, Behlouli H, Guo H, Pilote L. Warfarin use and the risk for stroke and bleeding in patients with atrial fibrillation undergoing dialysis. Circulation. 2014 Mar 18;129(11):1196-203. doi: 10.1161/CIRCULATIONAHA.113.004777. Epub 2014 Jan 22.

    PubMed 24452752

  • Granger CB, Chertow GM. A pint of sweat will save a gallon of blood: a call for randomized trials of anticoagulation in end-stage renal disease. Circulation. 2014 Mar 18;129(11):1190-2. doi: 10.1161/CIRCULATIONAHA.113.007549. Epub 2014 Jan 22. No abstract available.

    PubMed 24452751

  • Chan KE, Edelman ER, Wenger JB, Thadhani RI, Maddux FW. Dabigatran and rivaroxaban use in atrial fibrillation patients on hemodialysis. Circulation. 2015 Mar 17;131(11):972-9. doi: 10.1161/CIRCULATIONAHA.114.014113. Epub 2015 Jan 16.

    PubMed 25595139

  • Hart RG, Pearce LA, Asinger RW, Herzog CA. Warfarin in atrial fibrillation patients with moderate chronic kidney disease. Clin J Am Soc Nephrol. 2011 Nov;6(11):2599-604. doi: 10.2215/CJN.02400311. Epub 2011 Sep 8.

    PubMed 21903982

  • Reinecke H, Brand E, Mesters R, Schabitz WR, Fisher M, Pavenstadt H, Breithardt G. Dilemmas in the management of atrial fibrillation in chronic kidney disease. J Am Soc Nephrol. 2009 Apr;20(4):705-11. doi: 10.1681/ASN.2007111207. Epub 2008 Dec 17.

    PubMed 19092127

  • Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007 Jun 19;146(12):857-67. doi: 10.7326/0003-4819-146-12-200706190-00007.

    PubMed 17577005

  • Winkelmayer WC, Liu J, Setoguchi S, Choudhry NK. Effectiveness and safety of warfarin initiation in older hemodialysis patients with incident atrial fibrillation. Clin J Am Soc Nephrol. 2011 Nov;6(11):2662-8. doi: 10.2215/CJN.04550511. Epub 2011 Sep 29.

    PubMed 21959598

  • Hohnloser SH, Hijazi Z, Thomas L, Alexander JH, Amerena J, Hanna M, Keltai M, Lanas F, Lopes RD, Lopez-Sendon J, Granger CB, Wallentin L. Efficacy of apixaban when compared with warfarin in relation to renal function in patients with atrial fibrillation: insights from the ARISTOTLE trial. Eur Heart J. 2012 Nov;33(22):2821-30. doi: 10.1093/eurheartj/ehs274. Epub 2012 Aug 29.

    PubMed 22933567

  • Elliott MJ, Zimmerman D, Holden RM. Warfarin anticoagulation in hemodialysis patients: a systematic review of bleeding rates. Am J Kidney Dis. 2007 Sep;50(3):433-40. doi: 10.1053/j.ajkd.2007.06.017.

    PubMed 17720522

  • Wu JR, DeWalt DA, Baker DW, Schillinger D, Ruo B, Bibbins-Domingo K, Macabasco-O'Connell A, Holmes GM, Broucksou KA, Erman B, Hawk V, Cene CW, Jones CD, Pignone M. A single-item self-report medication adherence question predicts hospitalisation and death in patients with heart failure. J Clin Nurs. 2014 Sep;23(17-18):2554-64. doi: 10.1111/jocn.12471. Epub 2013 Dec 20.

    PubMed 24355060

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing apixaban and warfarin in people with Atrial Fibrillation and End Stage Renal Disease, run by Christopher Granger, MD at 58 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing ISTH (International Society on Thrombosis and Haemostasis) Major or Clinically Relevant Non-major Bleeding (time frame: Randomization up to Month 15/Final Visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02942407, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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