To determine the appropriate dose and safety of a preventative dose of fondaparinux, an anticoagulant medication (blood thinner) in patients with kidney disease.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
injections of 2.5mg every other day for 4 weeks
Duke University Medical Center
Durham, North Carolina, United States
PK parameters (half-life, area-under-the curve, and peak serum concentration)
Time frame: after day 7 and after day 27
Anti-factor Xa levels and assessment for bleeding(complete blood count)
Time frame: days 3, 13 and 19
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