Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01121770

Acronym

FONDA PK

Enrollment

Registered

2010-05-12

Start date

2010-05-31

Completion date

2013-02-28

Last updated

2014-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Insufficiency

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.

Interventions

DRUGfondaparinux sodium injection

1.5mg subcutaneously every day

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Blood samples to measure specific Arixtra® concentration	• 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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026