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

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ClinicalTrials.gov Identifier: NCT02942407
Recruitment Status : Recruiting
First Posted : October 24, 2016
Last Update Posted : December 11, 2018
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Christopher Granger, MD, Duke University

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) .

Condition or disease Intervention/treatment Phase
Atrial Fibrillation End Stage Renal Disease Drug: apixaban Drug: warfarin Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RENal Hemodialysis Patients ALlocated Apixaban Versus Warfarin in Atrial Fibrillation (RENAL-AF) Randomized Clinical Trial
Actual Study Start Date : December 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: apixaban
apixaban 5 mg twice daily (apixaban 2.5 mg twice daily for selected patients)
Drug: apixaban
oral anticoagulant
Other Name: Eliquis

Experimental: warfarin
warfarin daily dose adjusted to target International Normalized Ration(INR) of 2-3
Drug: warfarin
oral anticoagulant
Other Names:
  • Coumadin
  • Jantoven




Primary Outcome Measures :
  1. Time (measured in days) from randomization to the onset of first major bleeding/clinically relevant non-major bleeding event, as described by International Society of Thrombosis and Haemostasis (ISTH) [ Time Frame: 15 months ]

Secondary Outcome Measures :
  1. stroke or systemic embolism [ Time Frame: 15 months ]
  2. mortality [ Time Frame: 15 months ]
    all-cause death

  3. adherence to treatment with apixaban or with warfarin, measured by pill count for patients randomized to apixaban, and by time in therapeutic range (TTR) for warfarin [ Time Frame: 15 months ]
    including discontinuation for adverse events

  4. apixaban plasma concentration. [ Time Frame: Baseline: Day 3, 4, or 5; Day 28 ]
    Pharmacokinetics; only in the apixaban treated patients

  5. plasma apixaban concentration, Cmax [ Time Frame: Baseline: Day 3, 4, or 5; Day 28 ]
    Pharmacokinetics

  6. plasma apixaban concentration, Cmin [ Time Frame: Baseline: Day 3, 4, or 5; Day 28 ]
    Pharmacokinetics

  7. plasma apixaban concentration, area under the curve (AUC) [ Time Frame: Baseline: Day 3, 4, or 5; Day 28 ]
    Pharmacokinetics

  8. apixaban pharmacodynamics, chromogenic factor Xa assay [ Time Frame: Baseline: Day 3, 4, or 5; Day 28 ]
    Pharmacodynamics


Other Outcome Measures:
  1. baseline biomarkers to assess for prediction of clinical outcomes such as bleeding. Biomarkers to be assessed are Growth/differentiation factor 15(GDF-15), high sensitivity troponin T (hs-trop T), B-type natriuretic peptide (NT-proBNP). [ Time Frame: Baseline ]
    Biomarker



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02942407


Contacts
Contact: Pat Dignacco, BSMT 919-668-8482 pat.dignacco@duke.edu
Contact: Cynthia Blackwell cynthia.a.blackwell@duke.edu

  Show 58 Study Locations
Sponsors and Collaborators
Christopher Granger, MD
Bristol-Myers Squibb
Investigators
Principal Investigator: Christopher Granger, MD Duke University
Principal Investigator: Glenn Chertow, MD Stanford University

Additional Information:
Publications:

Responsible Party: Christopher Granger, MD, Professor of Medicine, Duke University
ClinicalTrials.gov Identifier: NCT02942407     History of Changes
Other Study ID Numbers: Pro00068545
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Christopher Granger, MD, Duke University:
Renal dialysis

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Urologic Diseases
Apixaban
Warfarin
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action