NCT02672709

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

4 months

First QC Date

January 12, 2016

Last Update Submit

August 29, 2016

Conditions

End-stage Renal Disease

Keywords

Factor Xa InhibitorsRenal Dialysis

Outcome Measures

Primary Outcomes (1)

  • Apixaban concentration

    Examine whether apixaban accumulates after an 8-day administration

    Day 8

Secondary Outcomes (2)

  • Apixaban concentration before, during, and after hemodialysis

    Before dialysis, then every hour until the end of dialysis on day 2 and day 9

  • Number of participants with treatment related adverse effects

    Day 1 to 9

Study Arms (1)

Anticoagulation

EXPERIMENTAL

Apixaban will be prescribed at the dose of 2.5 mg twice per day for nine days.

Drug: apixaban

Interventions

apixabanDRUG
Anticoagulation

Eligibility Criteria

Age19 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish General Hospital

Montreal, Canada

Location

Related Publications (3)

  • Verma A, Cairns JA, Mitchell LB, Macle L, Stiell IG, Gladstone D, McMurtry MS, Connolly S, Cox JL, Dorian P, Ivers N, Leblanc K, Nattel S, Healey JS; CCS Atrial Fibrillation Guidelines Committee. 2014 focused update of the Canadian Cardiovascular Society Guidelines for the management of atrial fibrillation. Can J Cardiol. 2014 Oct;30(10):1114-30. doi: 10.1016/j.cjca.2014.08.001. Epub 2014 Aug 13.

    PMID: 25262857BACKGROUND

  • 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.

    PMID: 24452751BACKGROUND

  • Wang X, Tirucherai G, Marbury TC, Wang J, Chang M, Zhang D, Song Y, Pursley J, Boyd RA, Frost C. Pharmacokinetics, pharmacodynamics, and safety of apixaban in subjects with end-stage renal disease on hemodialysis. J Clin Pharmacol. 2016 May;56(5):628-36. doi: 10.1002/jcph.628. Epub 2015 Dec 22.

    PMID: 26331581BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

apixaban

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

January 12, 2016

First Posted

February 3, 2016

Study Start

April 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 30, 2016

Record last verified: 2016-08

Locations

CA(1)