Pharmacokinetic Study of Fondaparinux in Outpatients With Renal Dysfunction

Duke University

Status: Withdrawn

Conditions: Kidney Diseases

Treatments: Drug: fondaparinux

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00483600

Pro00001571

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

no arms/one group

Experimental group

Treatment:

Drug: fondaparinux