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apixaban in end -stage renal disease

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003132-12-BE

Enrollment

Registered

2015-07-23

Start date

2015-11-20

Completion date

Unknown

Last updated

2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

the pharmacokinetics profile of Apixaban allows safe use in patients with end-stage renal disease

Interventions

Trade Name: Eliquis Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Belgium

Contacts

Public ContactBjorn Meijers

UZ Leuven

bjorn.meijers@uzleuven.be3216342409

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026

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