"Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction"

NCT01121770 | Completed Phase 1

• 2 other identifiers: Pro00021052112972
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Insufficiency

Outcome Measures

Primary Outcomes (1)

• Blood samples to measure specific Arixtra® concentration

  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 Outcomes (1)

• Frequency of bleeding events and new thrombotic events

  Daily assessments will be made for bleeding and thrombosis

Study Arms (1)

Arixtra

EXPERIMENTAL

Drug: fondaparinux sodium injection

Interventions

fondaparinux sodium injection DRUG

1.5mg subcutaneously every day

Arixtra

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Links

• The Duke Hemostasis \& Thrombosis Center provides a multidisciplinary approach to the diagnosis and management of a wide variety of hemostatic disorders and is a leader in basic research effort. Click here for more information about this study.

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Fondaparinux

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Oligosaccharides; Polysaccharides; Carbohydrates

Study Officials

• Thomas L Ortel, M.D, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2010
• First Posted: May 12, 2010
• Study Start: May 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: February 1, 2013
• Last Updated: September 1, 2014

Record last verified: 2014-08

Locations

US (1)