Chronic kidney disease, non-valvular atrial fibrillation MedDRA version: 21.0 Level: LLT Classification code 10076412 Term: Chronic kidney disease stage 5 System Organ Class: 100000004857 MedDRA version: 20.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: ELIQUIS
Pharmaceutical Form: Tablet
INN or Proposed INN: APIXABAN
Other descriptive name: EMEA/H/C/002148
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number
Sponsors
HOSPITAL UNIVERSITARI DE BELLVITGE- IDIBELL
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine plasma concentrations of apixaban before, during and after renal replacement techniques (hemodialysis and hemodiafiltration) in patients with chronic kidney disease and non-valvular atrial fibrillation;Secondary Objective: Pharmacokinetics: • Pharmacokinetic profile of the elimination of apixaban in the urine (in those patients with residual diuresis) and the dialysis fluid, during the study period of 4 weeks. Pharmacodynamics: • Anti-Factor Xa activity of apixaban before, during and after renal replacement techniques (hemodialysis and hemodiafiltration) in patients with chronic kidney disease and non-valvular atrial fibrillation. Safety: • Short-term safety (4 weeks) of apixaban in patients with chronic kidney disease (undergoing hemodialysis or haemodiafiltration) and non-valvular atrial fibrillation. Drug-economics: • Economic impact of anticoagulant treatment with apixaban compared to anticoagulant therapy with cumarinics in patients with chronic kidney disease (under treatment with hemodialysis or hemodiafiltration) and non-valvular atrial fibrillation.;Primary end point(s): Plasma concentration of apixaban.;Timepoint(s) of evaluation of this end point: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pharmacokinetics: • Concentration in urine and dialysis fluid of apixaban. Pharmacodynamics: • Anti Xa Factor activity of apixaban. Security: • Number of patients with medical complications not directly related to the disease base. • Total number of adverse events. • Number of adverse events related to the apixaban.;Timepoint(s) of evaluation of this end point: 28 days | — |
Countries
Spain
Contacts
Public ContactCAROLINA POLO
IDIBELL
Outcome results
None listed