PHARMACOKINETICS, PHARMACODYNAMICS AND SAFETY OF APIXABAN IN PATIENTS IN HEMODAFILTRATION - HEMOCIONA

HOSPITAL UNIVERSITARI DE BELLVITGE- IDIBE0 个研究点目标入组 20 人开始时间: 2019年7月26日最近更新: 2023年9月18日

试验速览

暂无简介。

•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

•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.

发起方

HOSPITAL UNIVERSITARI DE BELLVITGE- IDIBE