Pharmacokinetic Study of Fondaparinux in Outpatients With Renal Dysfunction

Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00483600
• Other study ID #: Pro00001571
• Status: Withdrawn
• Phase: N/A
• First received: June 5, 2007
• Last updated: July 25, 2014
• Start date: August 2007
• Est. completion date: August 2008

Study information

• Verified date: February 2011
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Insufficiency

Intervention

Drug:
• fondaparinux
injections of 2.5mg every other day for 4 weeks

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameters (half-life, area-under-the curve, and peak serum concentration)		after day 7 and after day 27
Secondary	Anti-factor Xa levels and assessment for bleeding(complete blood count)		days 3, 13 and 19