Apixaban in Hemodialysis

August 29, 2016 updated by: Mark L. Lipman, Jewish General Hospital

Pharmacokinetics and Pharmacodynamics of Apixaban in End-stage Renal Disease Patients on Hemodialysis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Montreal, Canada
        • Jewish General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apixaban concentration
Time Frame: Day 8
Examine whether apixaban accumulates after an 8-day administration
Day 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Before dialysis, then every hour until the end of dialysis on day 2 and day 9
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
Day 1 to 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jewish General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

January 12, 2016

First Submitted That Met QC Criteria

January 30, 2016

First Posted (Estimate)

February 3, 2016

Study Record Updates

Last Update Posted (Estimate)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #15-128

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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