Pharmacokinetic Study of Fondaparinux in Outpatients With Renal Dysfunction

Study Overview
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Brief Summary
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To determine the appropriate dose and safety of a preventative dose of fondaparinux, an anticoagulant medication (blood thinner) in patients with kidney disease.

Detailed Description
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This study will evaluate the PK of fondaparinux in patients who have renal insufficiency. Fondaparinux is cleared from the body mainly by the kidneys. Therefore in patients with kidney diseases, full doses of fondaparinux could cause bleeding problems. The correct dose of fondaparinux that should be used in patients with kidney disease is not known. The purpose of this research is to determine the PK and safety of a preventative dose (2.5mg subcutaneously every other day) of fondaparinux for patients with kidney disease.

Official Title
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Studies of Fondaparinux in Patients With Renal Dysfunction: PK Study of Fondaparinux in Outpatients With Renal Dysfunction

Conditions
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Kidney Diseases

Intervention / Treatment
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* Drug: fondaparinux


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients in the Medicine and Nephrology clinics who are 18 years or older, Outpatients in the Medicine and Nephrology clinics who have an estimated creatinine clearances between 20-30ml/min, Outpatients in the Medicine and Nephrology clinics who are able to give consent will be included. Exclusion Criteria: anticoagulation therapy for thrombosis or other indication pregnant or breast-feeding hypersensitivity to fondaparinux subjects also will be excluded if there is concern for an increased risk of bleeding which includes the following: known bleeding disorder (see Section 8. Hemostatic Assessment) blood transfusion in the past 3 months acute ulcer disease with past 3 months platelet count < 120,000 mm3 prolonged baseline prothrombin time (PT) or activated partial thromboplastin time (aPTT) above upper limit of normal laboratory range major trauma or surgery within two weeks prior to enrollment history of intracranial hemorrhage

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: no arms/one group<br> | Drug: fondaparinux<br>* injections of 2.5mg every other day for 4 weeks<br>* Other names: Arixtra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters (half-life, area-under-the curve, and peak serum concentration) |  | after day 7 and after day 27 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-factor Xa levels and assessment for bleeding(complete blood count) |  | days 3, 13 and 19 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fondaparinux, Pharmacokinetic