Back to results"Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction" (FONDA PK)
Primary Purpose
Renal Insufficiency
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
fondaparinux sodium injection
Sponsored by
About this trial
This is an interventional treatment trial for Renal Insufficiency
Eligibility Criteria
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.
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arixtra
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Frequency of bleeding events and new thrombotic events
events will be used to compare to rates in patients without renal dysfunction
Full Information
NCT ID
NCT01121770
First Posted
May 6, 2010
Last Updated
August 29, 2014
Sponsor
Duke University
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT01121770
Brief Title
"Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction"
Acronym
FONDA PK
Official Title
Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arixtra
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
fondaparinux sodium injection
Intervention Description
1.5mg subcutaneously every day
Primary Outcome Measure Information:
Title
Blood samples to measure specific Arixtra® concentration
Description
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
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
Secondary Outcome Measure Information:
Title
Frequency of bleeding events and new thrombotic events
Description
events will be used to compare to rates in patients without renal dysfunction
Time Frame
Daily assessments will be made for bleeding and thrombosis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas L Ortel, M.D, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Links:
URL
http://htc.medicine.duke.edu/
Description
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.
Learn more about this trial
"Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction"
We'll reach out to this number within 24 hrs