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    Summary
    EudraCT Number:2019-002353-29
    Sponsor's Protocol Code Number:HUB-NEF-HEMOCIONA.EC
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-07-26
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2019-002353-29
    A.3Full title of the trial
    PHARMACOKINETICS, PHARMACODYNAMICS AND SAFETY OF APIXABAN IN PATIENTS IN HEMODAFILTRATION
    FARMACOCINÉTICA, FARMACODINAMIA Y SEGURIDAD DE APIXABÁN EN PACIENTES EN HEMODIAFILTRACIÓN
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ACTIVITY AND SAFETY OF APIXABAN IN PATIENTS IN HEMODAFILTRATION
    ACTIVIDAD Y SEGURIDAD DE APIXABÁN EN PACIENTES EN HEMODIAFILTRACIÓN
    A.3.2Name or abbreviated title of the trial where available
    HEMOCIONA
    HEMOCIONA
    A.4.1Sponsor's protocol code numberHUB-NEF-HEMOCIONA.EC
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHOSPITAL UNIVERSITARI DE BELLVITGE- IDIBELL
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIDIBELL (INSTITUT DE RECERCA BIOMÈDICA DE BELLVITGE)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIDIBELL
    B.5.2Functional name of contact pointCAROLINA POLO
    B.5.3 Address:
    B.5.3.1Street AddressFEIXA LLARGA, S/N
    B.5.3.2Town/ cityL'HOSPITALET DE LLOBREGAT
    B.5.3.3Post code08907
    B.5.3.4CountrySpain
    B.5.4Telephone number+34932607385
    B.5.5Fax number+34932607385
    B.5.6E-mailcpolo@idibell.cat
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name ELIQUIS
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb / Pfizer EEIG
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAPIXABAN
    D.3.9.3Other descriptive nameEMEA/H/C/002148
    D.3.9.4EV Substance CodeSUB25425
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic kidney disease, non-valvular atrial fibrillation
    Enfermedad renal crónica, fibrilación auricular no valvular
    E.1.1.1Medical condition in easily understood language
    Chronic kidney disease, non-valvular atrial fibrillation
    Enfermedad renal crónica, fibrilación auricular no valvular
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10076412
    E.1.2Term Chronic kidney disease stage 5
    E.1.2System Organ Class 100000004857
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003658
    E.1.2Term Atrial fibrillation
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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
    Determinar las concentraciones plasmáticas de apixabán antes, durante y después de las técnicas de susttución renal (hemodiálisis y hemodiafiltración) en pacientes de nuestro entorno con enfermedad renal crónica y fibrilación auricular no valvular
    E.2.2Secondary objectives of the trial
    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.
    Farmacocinética:
    • Perfil farmacocinético de la eliminación de apixabán en la orina (en aquellos pacientes con diuresis residual) y el líquido de diálisis, durante el periodo de estudio de 4 semanas.

    Farmacodinamia:
    • Actividad anti-Factor Xa de apixabán antes, durante y después de las técnicas de sustitución renal (hemodiálisis y hemodiafiltración) en pacientes de nuestro entorno con enfermedad renal crónica y fibrilación auricular no valvular.

    Seguridad:
    • Seguridad a corto plazo (4 semanas) de apixabán en pacientes de nuestro entorno con enfermedad renal crónica (en tratamiento con hemodiálisis o hemodiafiltración) y fibrilación auricular no valvular.

    Fármaco-economía:
    • Impacto económico del tratamiento anticoagulante con apixabán respecto al tratamiento anticoagulante con cumarinicos en pacientes de nuestro entorno con enfermedad renal crónica (en tratamiento con hemodiálisis o hemodiafiltración) y fibrilación auricular no valvular.
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    • Adultos (18 años o más)
    • Peso corporal ≥ 60kg.
    • Diagnóstico de enfermedad renal crónica en hemodiálisis (con un mínimo de 3 meses de tratamiento), estables clínicamente, y de fibrilación auricular no valvular en tratamiento con cumarínicos
    • Paciente candidato a cambio de tratamiento anticoagulante.
    • El sujeto otorga el consentimiento informado.
    E.4Principal 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.
    Criterios de exclusión:
    • Mujeres embarazadas o lactantes.
    • Peso corporal ≤ 60kg.
    • Presencia de hepatopatía (pacientes con valores elevados de enzima hepáticos ALT/AST>2x el límite
    superior de la normalidad, o Bilirrubina total > 1.5 LSN).
    • Trombopenia (<100.000 plaquetas/mL).
    • Estar en tratamiento con otros anticoagulantes (heparinas) o fármacos antiagregantes plaquetarios.
    • Estar en tratamiento con inhibidores enzimáticos (como antimicóticos azolicos o inhibidores de la
    proteasa del HIV) o inductores enzimáticos (como rifampicina, fenobarbital, carbamazepina, o fenitoina)
    del citocromo P450 3A4.
    • Antecedentes de episodio de sangrado en el último mes.
    • Presencia de alteraciones clínicas o analíticas no atribuibles al estadio de enfermedad renal.
    • Participación en otro ensayo clínico de tratamiento farmacológico.
    E.5 End points
    E.5.1Primary end point(s)
    Plasma concentration of apixaban.
    Concentración plasmática de apixabán.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    28 días
    E.5.2Secondary 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.
    Farmacocinética:
    • Concentración en orina y en líquido de diálisis de apixabán.
    Farmacodinamia:
    • Actividad anti-Factor Xa de apixaban.
    Seguridad:
    • Número de pacientes con complicaciones médicas no directamente relacionadas con la enfermedad de
    base.
    • Número total de acontecimientos adversos.
    • Número de acontecimientos adversos relacionados con el apixabán.
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days
    28 días
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    the expected normal treatment of that condition
    el tratamiento normal esperado de esa condición
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-09-05
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