NCT01590823

Brief Summary

Patients with end stage renal disease carry a high risk for atrial fibrillation (AF) and require oral anticoagulant therapy for prevention of stroke. Often, the oral anticoagulant, warfarin sodium, is prescribed. Managing dialysis patients on warfarin can be fraught will difficulties given the multitude of drug and food interactions, need for frequent coagulation monitoring and dosage adjustment, and concern that warfarin enhances vascular calcification in dialysis patients. Recently, dabigatran etexilate, a direct oral thrombin inhibitor, has been approved for use in AF patients with normal renal function. Since many drugs are eliminated by the kidneys and removed from the plasma during dialysis, it is important to determine proper drug dosing in hemodialysis patients through evaluating pharmacokinetics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_1

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

April 20, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 3, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

November 1, 2012

Status Verified

April 1, 2012

Enrollment Period

2 months

First QC Date

April 20, 2012

Last Update Submit

October 31, 2012

Conditions

Blood Coagulation Disorders

Keywords

pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics following a single dose of dabigatran etexilate in hemodialysis patients.

    Dabigatran plasma concentration following a single dose of dabigatran etexilate in hemodialysis patients

    0,0.5,1,2,3,4,12,24, and 48 hours post dose following single dabigatran dose

Secondary Outcomes (1)

  • Fraction of dabigatran in the blood removed by dialysis.

    0,1,2,3 and 4 hours post dose

Study Arms (1)

Dabigatran etexilate 110 mg

OTHER

Single dose of Dabigatran etexilate 110 mg po

Drug: Dabigatran Etexilate 110 mg

Interventions

Dabigatran Etexilate 110 mgDRUG

All participants will receive a single dosage of dabigatran etexilate 110 mg at the start of their 4 hour dialysis session. Blood sampling will be conducted during and up to 48 hours after participant's dialysis session.

Also known as: Dabigatran Etexilate 110 mg (Pradax)
Dabigatran etexilate 110 mg

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between 18 and 75 years receiving hemodialysis at the Capital District Health Authority Renal Program who are receiving or who are good candidates for normal saline flushes for prevention of extracorporeal circuit clotting will be eligible for this study.

You may not qualify if:

  • know bleeding diathesis;
  • geographic inaccessibility for follow-up of timed blood sampling;
  • use of any anticoagulant drugs that might influence results within 48 hours of the study;
  • history of allergy/hypersensitivity (including drug allergy) deemed relevant to the trial by the investigators;
  • recent or planned diagnostic or therapeutic procedures with potential for bleeding within 14 days before or after drug administration;
  • history of familial bleeding disorder;
  • history of relevant orthostatic hypotension, fainting spells or blackouts;
  • disease of the central nervous system (such as epilepsy);
  • chronic or relevant acute infection; and
  • use of medication known to potentially increase or decrease dabigtran exposure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital Health District Authority, Department of Medicine, Division of Nephrology

Halifax, Nova Scotia, b3h 2y9, Canada

Location

Related Publications (1)

  • Wilson JA, Goralski KB, Soroka SD, Morrison M, Mossop P, Sleno L, Wang Y, Anderson DR. An evaluation of oral dabigatran etexilate pharmacokinetics and pharmacodynamics in hemodialysis. J Clin Pharmacol. 2014 Aug;54(8):901-9. doi: 10.1002/jcph.335. Epub 2014 May 28.

    PMID: 24846496DERIVED

MeSH Terms

Conditions

Blood Coagulation Disorders

Interventions

Dabigatran

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • jo-anne wilsoon, PharmD

    CDHA Renal Program

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2012

First Posted

May 3, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

November 1, 2012

Record last verified: 2012-04

Locations

CA(1)