ACTIVITY AND SAFETY OF APIXABAN IN PATIENTS IN HEMODAFILTRATIO

Phase 1

• Conditions: Chronic kidney disease, non-valvular atrial fibrillation; MedDRA version: 21.0Level: LLTClassification code 10076412Term: Chronic kidney disease stage 5System Organ Class: 100000004857; MedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2019-002353-29-ES
• Lead Sponsor: HOSPITAL UNIVERSITARI DE BELLVITGE- IDIBE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-26
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

     • Adults (18 years or older)
     • Body weight = 60kg.
     • Diagnosis of chronic kidney disease in hemodialysis (with a minimum of 3 months of treatment), clinically stable, and non-valvular atrial fibrillation in treatment with coumarins
     • Patient candidate to a change in current anticoagulant treatment.
     • The subject gives 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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

    • Pregnant or lactating women.
     • Body weight = 60kg.
     • Presence of liver disease (patients with elevated liver enzyme ALT / AST> 2x the upper limit of normal, or
total bilirubin> 1.5 ULN).
     • Thrombopenia (<100,000 platelets / mL).
     • Be in treatment with other anticoagulants (heparins) or antiplatelet drugs.
     • Being treated with enzymatic inhibitors (such as azole antifungals or HIV protease inhibitors) or enzyme
inducers (such as rifampicin, phenobarbital, carbamazepine, or phenytoin) of cytochrome P450 3A4.
     • History of bleeding episode in the last month.
     • Presence of clinical or analytical alterations not attributable to the stage of kidney disease.
• Participation in another clinical trial of pharmacological treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified