"Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction" (FONDA PK)

August 29, 2014 updated by: Duke University

Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction

The purpose of this study is to determine a preventative dose of study drug, Arixtra® for patients with kidney disease. We will measure the blood levels of Arixtra® in patients with kidney disease and develop guidelines for dosing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

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

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inpatients who are 18 years or older
  • estimated creatinine clearances between 20-50 ml/min
  • current hospitalization for a cancer-related abdominal, breast surgery or elective orthopedic surgery
  • able to give informed consent
  • need for prophylactic anticoagulant therapy for increased risk of a thrombotic episode

Exclusion Criteria: Use of the following

  • clopidogrel, aspirin, or NSAID usage,(usage is prohibited while patients are participating in the study)
  • body weight < 50 kg
  • anticoagulation therapy for thrombosis or other indication
  • pregnant or breast-feeding
  • hypersensitivity to Arixtra®
  • thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of Arixtra®
  • bacterial endocarditis
  • brain malignancy
  • increased risk of bleeding.

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arixtra
Drug: fondaparinux sodium injection
1.5mg subcutaneously every day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood samples to measure specific Arixtra® concentration
Time Frame: • Three blood samples for PK analyses will be obtained within the 24 hour period immediately following either the third or fourth consecutive dose of Arixtra
peak level will be collected 2-3 hours after the dose interval level will be collected between peak and midpoint midpoint level will be collected 12 hours after the dose interval level will be collected midpoint and trough trough level will be collected just prior to the next scheduled dose
• Three blood samples for PK analyses will be obtained within the 24 hour period immediately following either the third or fourth consecutive dose of Arixtra

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of bleeding events and new thrombotic events
Time Frame: Daily assessments will be made for bleeding and thrombosis
events will be used to compare to rates in patients without renal dysfunction
Daily assessments will be made for bleeding and thrombosis

Collaborators and Investigators

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

Sponsor

Duke University

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Thomas L Ortel, M.D, PhD, Duke University

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.

Helpful Links

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

May 1, 2010

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

May 6, 2010

First Submitted That Met QC Criteria

May 10, 2010

First Posted (Estimate)

May 12, 2010

Study Record Updates

Last Update Posted (Estimate)

September 1, 2014

Last Update Submitted That Met QC Criteria

August 29, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00021052
  • 112972

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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