Pharmacokinetic Study of Fondaparinux in Outpatients With Renal Dysfunction

Sponsor

Duke University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00483600

Collaborator

GlaxoSmithKline (Industry)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Kidney Diseases	Drug: fondaparinux	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Aug 1, 2007

Anticipated Study Completion Date :

Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: no arms/one group	Drug: fondaparinux injections of 2.5mg every other day for 4 weeks Other Names: Arixtra

Arm

Intervention/Treatment

Experimental: no arms/one group

Drug: fondaparinux

injections of 2.5mg every other day for 4 weeks

Other Names:

Arixtra

Outcome Measures

Primary Outcome Measures

PK parameters (half-life, area-under-the curve, and peak serum concentration) [after day 7 and after day 27]

Secondary Outcome Measures

Anti-factor Xa levels and assessment for bleeding(complete blood count) [days 3, 13 and 19]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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