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OpenTrials
Completed

NCT Number: NCT02672709

Apixaban in 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.

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Key information

Conditions

End-stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jewish General Hospital

Montreal, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apixaban

Drug

Primary outcomes

  1. Apixaban concentration

    Time frame: Day 8

    Examine whether apixaban accumulates after an 8-day administration

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Jewish General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 3, 2016
Registry last updated
Aug 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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