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Apixaban in Hemodialysis

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ClinicalTrials.gov Identifier: NCT02672709
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
Mark L. Lipman, Jewish General Hospital

Brief Summary:
This study aims to determine the effects of end-stage renal disease on the pharmacokinetics, pharmacodynamics, safety, and tolerability of apixaban. This is a single-center open-label pharmacological study. Apixaban will be prescribed at the dose of 2.5 mg twice per day for nine days. The concentration of the drug will be measured with repetitive blood tests the first and the eighth day of administration (non-dialysis days). The same blood tests will be repeated before, during, and after dialysis on dialysis days. If the study shows inadequate or suboptimal efficacy with the 2.5 mg dose, it will be repeated with the 5 mg twice-daily dose.

Condition or disease Intervention/treatment Phase
End-stage Renal Disease Drug: apixaban Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Pharmacokinetics and Pharmacodynamics of Apixaban in End-stage Renal Disease Patients on Hemodialysis
Study Start Date : April 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban

Arm Intervention/treatment
Experimental: Anticoagulation
Apixaban will be prescribed at the dose of 2.5 mg twice per day for nine days.
Drug: apixaban



Primary Outcome Measures :
  1. Apixaban concentration [ Time Frame: Day 8 ]
    Examine whether apixaban accumulates after an 8-day administration


Secondary Outcome Measures :
  1. Apixaban concentration before, during, and after hemodialysis [ Time Frame: Before dialysis, then every hour until the end of dialysis on day 2 and day 9 ]
    Apixaban levels to be measured before dialysis, then every hour until the end of dialysis on day 2 and day 9

  2. Number of participants with treatment related adverse effects [ Time Frame: Day 1 to 9 ]
    Short-term treatment related adverse effects: bleeding events, allergic reactions, any other symptom reported by the patient that could be attributed to the drug



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Ages Eligible for Study:   19 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age>18 years
  • end-stage renal disease on stable hemodialysis treatment (3 weekly sessions of 4 hours) for at least 6 months
  • no residual kidney function
  • non-valvular atrial fibrillation

Exclusion Criteria:

  • age ≥80 years
  • Body mass index (BMI)<21 or BMI>40
  • active bleeding
  • high bleeding risk (HAS BLED score >3)
  • active malignancy
  • psychiatric disorders
  • decompensated thyroid disorders
  • decompensated heart failure
  • acute myocardial infarction-cerebrovascular accident-head trauma in the last 3 months
  • previous history of venous thromboembolic disease in the last 6 months
  • previous history of coagulopathy already treated by vitamin K antagonists (VKAs) or novel oral anticoagulants
  • uncorrected rhythm or conduction disturbances
  • dual antiplatelet therapy
  • known liver disease or elevated transaminases > 2x upper limit of normal
  • Hemoglobin < 90 g/l
  • platelets < 100,000 /ml
  • known hypersensitivity to apixaban
  • treatment with a potent inhibitor or inducer of the cytochrome P450 3A4 and/or P-glycoprotein
  • absence of effective contraception where applicable
  • drug or alcohol abuse

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): NCT02672709


Locations
Canada
Jewish General Hospital
Montreal, Canada
Sponsors and Collaborators
Jewish General Hospital

Publications:
Responsible Party: Mark L. Lipman, Associate Professor of Medicine, Jewish General Hospital
ClinicalTrials.gov Identifier: NCT02672709     History of Changes
Other Study ID Numbers: #15-128
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016

Keywords provided by Mark L. Lipman, Jewish General Hospital:
Factor Xa Inhibitors
Renal Dialysis

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Apixaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants