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    Summary
    EudraCT Number:2015-001005-13
    Sponsor's Protocol Code Number:ANE-FERRO-2015
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-06-01
    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 number2015-001005-13
    A.3Full title of the trial
    Randomized open label clinical trial to compare two regimens of intravenous iron therapy after colorectal neoplastic surgery.
    Ensayo clínico aleatorizado abierto que compara dos pautas de ferroterapia endovenosa en el postoperatorio de cirugía neoplásica colorectal.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized open label clinical trial to compare two regimens of intravenous iron therapy after colorectal cancer surgery.
    Ensayo clínico aleatorizado abierto que compara dos pautas de tratamiento con hierro endovenoso después de una de cirugía por cáncer de colon.
    A.4.1Sponsor's protocol code numberANE-FERRO-2015
    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 SponsorFundació Parc Taulí
    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 supportFundació Parc Taulí
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitari Parc Taulí
    B.5.2Functional name of contact pointOficina de Recerca
    B.5.3 Address:
    B.5.3.1Street AddressParc Taulí, 1
    B.5.3.2Town/ citySabadell
    B.5.3.3Post code08208
    B.5.3.4CountrySpain
    B.5.4Telephone number34937458451
    B.5.5Fax number34937175067
    B.5.6E-mailafarre@tauli.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 Ferinject
    D.2.1.1.2Name of the Marketing Authorisation holderVifor France SA
    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.3.1Product nameFerinject
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNFERRIC CARBOXYMALTOSE
    D.3.9.1CAS number 9007-72-1
    D.3.9.4EV Substance CodeSUB66620
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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.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.2.1.2Country 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 Solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNIRON SUCROSE
    D.3.9.1CAS number 8047-67-4
    D.3.9.4EV Substance CodeSUB16439MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.IMP: 3
    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.2.1.2Country 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 Prolonged-release 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 INNFERROUS SULFATE
    D.3.9.1CAS number 7720-78-7
    D.3.9.4EV Substance CodeSUB13877MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    The medical condition being studied is anemia after a neoplastic colorectal surgery.
    La condición médica que se estudia es la anemia en el postoperatorio de cirugía neoplásica colorrectal.
    E.1.1.1Medical condition in easily understood language
    The medical condition being studied is anemia after colorectal cancer surgery.
    La condición médica que se está estudiando es la anemia después de cirugía para cáncer colorrectal.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10071378
    E.1.2Term Ferropenic anemia
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of two iron regimens for the treatment of postoperative anemia in patients undergoing colorectal neoplasia surgery.
    Comparar la eficacia de dos pautas de tratamiento con hierro en pacientes intervenidos de una neoplasia de colon en el tratamiento de la anemia postoperatoria.
    E.2.2Secondary objectives of the trial
    Compare the percentage of patients with Hb levels> 13 g / dL, with Hb between 11 and 12 g / dL and <11g / dL at day 30 postsurgery with two different regimens of iron therapy.
    Describe the number of patients with mild, moderate or severe postoperative anemia on day 30.
    Compare iron metabolism at day 30 (iron, ferritin, transferrin, % transferrin saturation).
    Compare the total dose of intravenous and oral iron administered at day 30 postsurgery.
    Compare resource utilization: hospital readmissions, number of days hospitalized at day 30 postsurgery.
    Compare transfusion rate postoperatively.
    Compare postoperative complications.
    Compare adverse effects associated with iron therapy.
    Describe compliance with ambulatory oral iron therapy.
    Compare the quality of life with both treatment regimens at day 30 postsurgery.
    Comparar el porcentaje de pacientes con niveles de Hb > 13g/dL, con Hb entre 11 y 12 g/dL y con < 11g/dL al día 30 postoperatorio con dos pautas diferentes de ferroterapia.
    Describir el número de pacientes con anemia leve, moderada o grave el día 30 de postoperatorio.
    Comparar el metabolismo de hierro a los 30 días (hierro, ferritina, transferrina, % de saturación de la transferrina).
    Comparar la dosis total de hierro endovenoso y oral administrada a día 30 de postoperatorio.
    Comparar la utilización de recursos: reingresos hospitalarios, número de días ingresados a los 30 días.
    Comparar la tasa transfusional en el postoperatorio.
    Comparar las complicaciones postoperatorias.
    Comparar los efectos adversos asociados al tratamiento con hierro.
    Describir el cumplimiento del tratamiento con hierro oral en domicilio.
    Comparar la calidad de vida a los 30 días con ambas formas de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients older than 18 years who undergo neoplastic surgery of colorectal cancer.
    Patients with a hemoglobin <= 11 g / dL on day 1 after neoplastic surgery.
    Patients that give their informed consent to participate in the study.
    Pacientes mayores de 18 años que se someten a cirugía neoplásica de cáncer colorrectal.
    Pacientes que presentan una hemoglobina <= 11 g/dL el día 1 de postoperatorio de cirugía colorrectal por patología neoplásica.
    Pacientes que otorguen su consentimiento informado a participar en el estudio.
    E.4Principal exclusion criteria
    Patients who on day 1 after colonic neoplastic surgery have Hb levels > 11g / dL.
    Patients who have had adverse reactions to intravenous iron or a contraindication to intravenous iron according to the SmPC.
    Patients with ASA anesthetic risk grade 4.
    Patients presenting postoperative complications Claviens grade 4.
    Pregnant or lactating women.
    Any circumstance that in the opinion of the responsible physician may cause the patient any harm or may interfere with the study assessments
    Pacientes postoperados de neoplasia de colon de forma electiva que presentan Hb > 11g/dL el día 1 de postoperatorio.
    Pacientes que han presentado reacciones adversas al hierro endovenoso anteriormente o contraindicación al hierro endovenoso según ficha técnica.
    Pacientes con nivel de riesgo anestésico ASA 4.
    Pacientes que presentan complicaciones postoperatorias grado 4 de Claviens.
    Mujeres embarazadas o en período de lactancia.
    Cualquier circunstancia que a criterio del médico le pueda suponer un riesgo o perjuicio clínico la participación del paciente en el estudio ó que interfiera en las valoraciones del mismo.
    E.5 End points
    E.5.1Primary end point(s)
    Change in hemoglobin levels from postoperative day 1 to day 30
    El cambio en los niveles de hemoglobina desde el día 1 al 30 de postoperatorio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 4 postsurgery
    Day 30 postsurgery
    Día 4 postoperatorio.
    Día 30 postoperatorio.
    E.5.2Secondary end point(s)
    Percentage of patients that reach Hb levels > 13g/dL
    Percentage of patients discontinuing treatment with oral iron.
    Changes in values of iron metabolism parameters at 30 days (iron, ferritin, transferrin,% transferrin saturation).
    Total dose of iron received within 30 days after surgery.
    Number of transfusions postoperatively.
    Number of medical and surgery complications.
    Adverse effects reported by the patient.
    Use of healthcare resources in the postoperative period: Number of readmissions, number of days hospitalized at 30 days.
    Changes in scores of quality of life questionnaire QLQ-C30.
    Se considerará variable secundaria clave o principal el porcentaje de pacientes que alcanzan un valor de Hb de 13g/dL
    Porcentaje de pacientes que abandonan el tratamiento con hierro oral.
    Cambios en los valores de los parámetros de metabolismo de hierro a los 30 días (hierro, ferritina, transferrina, % de saturación de la transferrina).
    Dosis total de hierro recibido durante los 30 primeros días de postoperatorio.
    Numero de transfusiones realizadas en el postoperatorio.
    Número de complicaciones médicas y quirúrgicas.
    Efectos adversos descritos por el paciente.
    Uso de recursos sanitarios en el postoperatorio: nº de reingresos, número de días ingresados a los 30 días.
    Cambios en la puntuación del cuestionario de calidad de vida QLQ-C30.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 4 postsurgery
    Day 30 postsurgery
    Día 4 postoperatorio.
    Día 30 postoperatorio.
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.2.4Number of treatment arms in the trial2
    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
    Last patient last visit
    Ultima visita del último paciente
    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 months9
    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: 48
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state96
    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)
    None
    No
    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 Decision2015-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-21
    P. End of Trial
    P.End of Trial StatusOngoing
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