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Phase 1
- Conditions
- the pharmacokinetics profile of Apixaban allows safe use in patients with end-stage renal diseaseTherapeutic area: Not possible to specify
- Registration Number
- EUCTR2015-003132-12-BE
- Lead Sponsor
- ZLeuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
patients aged 18 to 85 years, treated with maintenance dialysis thrice weekly, written and signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12
Exclusion Criteria
treated with oral vitamin K antagonists, recent major surgery, recent severe bleeding episode requiring blood transfusion and / or hospitalization, concurrent moderate to severe liver dysfunction
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to determine inter-dialytic pharmacokinetics of Apixaban;Secondary Objective: dose-finding of Apixaban in patients treated with hemodialysis;Primary end point(s): to determine inter-dialytic pharmacokinetics of different doses of Apixaban
- Secondary Outcome Measures
Name Time Method Secondary end point(s): anti-Xa activity during the interdialytic interval vs. the following intre-dialytic interval using a validated chromogenetic anti-Xa assay, bleeding time vascular access post-dialysis, occurence of bleeding events