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Completed

NCT Number: NCT01121770

"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.

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Key information

Conditions

Renal Insufficiency Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

fondaparinux sodium injection

Drug

1.5mg subcutaneously every day

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction

Acronym: FONDA PK

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
May 12, 2010
Registry last updated
Sep 1, 2014

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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