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    Summary
    EudraCT Number:2010-018961-50
    Sponsor's Protocol Code Number:AMAG-FER-IDA-302
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-08-09
    Trial results View 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 number2010-018961-50
    A.3Full title of the trial
    Ensayo en fase III, abierto, aleatorizado, con control activo que compara el ferumoxitol con la sacarosa férrica para el tratamiento de la anemia por deficiencia de hierro

    A Phase III, Randomized, Open-label, Active-Controlled Trial Comparing Ferumoxytol with Iron Sucrose for the Treatment of Iron Deficiency Anemia
    A.4.1Sponsor's protocol code numberAMAG-FER-IDA-302
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAMAG Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Feraheme
    D.2.1.1.2Name of the Marketing Authorisation holderAMAG Pharmaceuticals, Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.1Product nameferumoxitol
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNferumoxitol
    D.3.9.1CAS number 722492-56-0
    D.3.9.2Current sponsor code5128; ferumoxytol Drug Substance
    D.3.9.3Other descriptive namepolyglucose sorbitol carboxymethylether (PCS) superparamagnetic iron oxide
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Venofer®
    D.2.1.1.2Name of the Marketing Authorisation holderAmerican Regent, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 8047674
    D.3.9.3Other descriptive nameSacarosa Férrica
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Anemia por deficiencia de hierro
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level LLT
    E.1.2Classification code 10022975
    E.1.2Term Anemia por déficit de hierro secundario a la pérdida (crónica) de sangre
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level LLT
    E.1.2Classification code 10022976
    E.1.2Term Anemia por déficit de hierro secundario a su ingestión inadecuada en la dieta
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la eficacia y la seguridad de 1,02 g de ferumoxitol IV, administrado en forma de dos dosis de 510 mg cada una, en comparación con 1,0 g de sacarosa férrica, administrado en forma de cinco dosis de 200 mg cada una, para el tratamiento de la anemia por deficiencia de hierro (ADH)
    E.2.2Secondary objectives of the trial
    No hay objetivos secuandarios en el ensayo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Varones y mujeres &#8805; 18 años de edad
    2.Pacientes con ADH definida como:
    a)hemoglobina < 10,0 g/dl
    b)SATT < 20%
    3. Pacientes con antecedentes de tratamiento insatisfactorio con hierro oral o en los que no puede utilizarse hierro oral (se incluyen pacientes que siguen con anemia a pesar de recibir tratamiento con hierro oral, que tienen efectos secundarios que descartan el uso de tratamiento con hierro oral o que no pueden tomar hierro oral por otros motivos)
    4. Las mujeres en edad fértil que sean sexualmente activas deberán utilizar un método anticonceptivo eficaz durante al menos un mes antes de la selección y comprometerse a seguir utilizándolo hasta la finalización de su participación en el estudio
    5. El paciente es capaz de comprender y cumplir los requisitos del protocolo y se encontrará disponible durante la totalidad del estudio
    6. El paciente ha sido informado de la naturaleza de investigación de este estudio y ha otorgado su consentimiento informado voluntario por escrito y, si procede, de la Health Insurance Portability and Accountability Act (HIPAA) o la autorización de protección del paciente de conformidad con las normas institucionales, locales y nacionales sobre la protección de datos sanitarios personales
    E.4Principal exclusion criteria
    1. Antecedentes de alergia al hierro IV
    2. Alergia a dos o más clases de medicamentos
    3. Pacientes en diálisis o con una tasa de filtración glomerular estimada (TFGe) < 30 ml/min/1,73 m2
    4. Mujeres que están embarazadas, tienen intención de quedarse embarazadas, están en período de lactancia, se encuentran en las dos semanas posteriores al parto o tienen una prueba de embarazo en suero u orina positiva
    5. Hemoglobina &#8804; 7,0 g/dl
    6. Ferritina sérica > 600 ng/ml
    7. Tratamiento con hierro parenteral en las cuatro semanas anteriores a la selección, tratamiento con hierro oral en las dos semanas anteriores a la selección o transfusión de hematíes o sangre entera en las dos semanas anteriores a la selección o prevista durante el estudio
    8. Inicio, interrupción o modificación de la dosis en > 20% de un tratamiento con medicamentos estimuladores de la eritropoyesis (MEE) en las cuatro semanas anteriores a la selección o modificación prevista de la dosis de MEE > 20% durante el estudio
    9. Causas conocidas de anemia distintas de la deficiencia de hierro (p. ej., hemólisis, deficiencia de vitamina B12 o folato, etc.)
    10. Operación de cirugía mayor o intervención cruenta en las cuatro semanas anteriores a la selección, trasplante de órgano en los seis meses anteriores a la selección o cualquier operación quirúrgica o intervención prevista durante el transcurso del estudio
    11. Inicio reciente (en los dos meses anteriores a la selección) o modificación del tratamiento para controlar una hemorragia (p. ej., azatioprina o 6-mercaptopurina por enfermedad inflamatoria intestinal [EII], tratamiento hormonal por hemorragia uterina anormal [HUA]) o previsión de modificar el tratamiento durante el estudio
    12. Infección activa con importancia clínica o enfermedad médica grave aguda (con la excepción de cáncer) que precise tratamiento o intervención en las dos semanas anteriores a la selección
    13. En los pacientes con cáncer (es decir, diagnóstico histológico de neoplasia maligna no hematológica), un estado funcional del Eastern Cooperative Oncology Group (ECOG) > 2 o una esperanza de vida < 24 semanas, así como > 2 ciclos o regímenes previos de quimioterapia o radioterapia sobre > 40% de la médula ósea en los dos años precedentes o antecedentes o preparación para un trasplante de médula ósea
    14. Recepción de otro medicamento en investigación en las cuatro semanas anteriores a la selección o recepción prevista de un medicamento en investigación no especificado por este protocolo durante el período del estudio
    15. Cualquier otra enfermedad o proceso médico con importancia clínica (p. ej., hipertensión arterial no controlada) o responsabilidad del paciente que, en opinión del investigador, podría interferir en la capacidad del paciente para otorgar su consentimiento informado, cumplir el protocolo, interferir en la evaluación del producto en investigación o constituir una contraindicación a la participación del paciente en el estudio
    E.5 End points
    E.5.1Primary end point(s)
    Proporción de pacientes que logren un aumento de la hemoglobina &#8805; 2,0 g/dl en cualquier momento entre el momento basal y la semana 5
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA101
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    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
    El final del ensayo está definido como la últim avisuta del último sujeto.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 467
    F.4.2.2In the whole clinical trial 600
    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 Decision2010-10-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-11-09
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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