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Keep this study
Lead
Bristol-Myers Squibb
Primary Purpose : To provide a clear understanding of the pharmacokinetics of Apixaban in subjects with ESRD and to determine the effect of hemodialysis on Apixaban pharmacokinetics .
Age
18–65
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
The signed informed consent form.
Subjects with normal renal function classified based on calculated creatinine clearance (CLCr) determined by the cockcroft-gault calculation.
Eligible subjects with ESRD that is maintained with chronic and stable hemodialysis.
You may not be if
Any history of abnormal bleeding or coagulation disorders including those in a first degree relative under 50 years of age.
History of significant head injury within the last two years.
Any gastrointestinal surgery that could impact the absorption of study drug.
Not expected to continue the hemodialysis treatment for the duration of the study.
INR, PT, or aPTT above the upper limit of normal, unless agreed upon between the investigator and BMS medical monitor.
History of allergy to Apixaban or Factor Xa inhibitors.
Clareo Health | Pharmacokinetics and Pharmacodynamics of Apixaban in Subjects on Hemodialysis