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    Summary
    EudraCT Number:2018-003714-40
    Sponsor's Protocol Code Number:IRONPAD
    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:2019-04-11
    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 number2018-003714-40
    A.3Full title of the trial
    IMPACT OF INTRAVENOUS IRON TREATMENT OF PREOPERATIVE ANEMIA IN PATIENTS WITH LOWER EXTREMITY PERIPHERAL ARTERY DISEASE
    IMPACTO DEL HIERRO INTRAVENOSO EN EL TRATAMIENTO PREOPERATORIO DE LA ANEMIA EN PACIENTES CON ISQUEMIA CRÓNICA DE LOS MIEMBROS INFERIORES
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    IMPACT OF INTRAVENOUS IRON TREATMENT OF PREOPERATIVE ANEMIA IN PATIENTS WITH LOWER EXTREMITY PERIPHERAL ARTERY DISEASE
    IMPACTO DEL HIERRO INTRAVENOSO EN EL TRATAMIENTO PREOPERATORIO DE LA ANEMIA EN PACIENTES CON ISQUEMIA CRÓNICA DE LOS MIEMBROS INFERIORES
    A.3.2Name or abbreviated title of the trial where available
    IRONPAD
    A.4.1Sponsor's protocol code numberIRONPAD
    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 SponsorServicio de Angiología y Cirugía Vascular del Hospital Universitario Cruces
    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 supportServicio de Angiología y Cirugía vascular del Hospital Universitario Cruces
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationServicio de Angiología y Cirugía Vascular del Hospital Universitario Cruces
    B.5.2Functional name of contact pointServicio Vascular
    B.5.3 Address:
    B.5.3.1Street AddressPlaza de Cruces, S/N
    B.5.3.2Town/ cityBarakaldo, Bilbao
    B.5.3.3Post code48903
    B.5.3.4CountrySpain
    B.5.4Telephone number34946006000
    B.5.5Fax number34946006000
    B.5.6E-mailANA.APODAKADIEZ@osakidetza.eus
    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
    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 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 number1.000
    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.2.1.1.1Trade name TARDYFERON
    D.2.1.1.2Name of the Marketing Authorisation holderPIERRE FABRE IBÉRICA, S.A.
    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 nameTARDYFERON
    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 INNIRON SULFATE DIHYDRATE
    D.3.9.2Current sponsor codeIRON SULFATE DIHYDRATE
    D.3.9.3Other descriptive nameIRON SULFATE DIHYDRATE
    D.3.9.4EV Substance CodeSUB121234
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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
    Anemia in patients with chronic lower limb ischemia
    Anemia en pacientes con isquemia crónica de miembros inferiores
    E.1.1.1Medical condition in easily understood language
    Anemia in patients with chronic lower limb ischemia
    Anemia in patients with chronic lower limb ischemia
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10002272
    E.1.2Term 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
    Reduce the incidence of transfusion from randomization up to 30 days after the main surgery in patients with anemia who undergo revascularization surgery with chronic lower limb ischemia
    Reducir la incidencia de transfusión desde la randomización hasta 30 días después de la cirugía principal en pacientes con anemia que son sometidos a cirugía de revascularización con isquemia crónica de miembros inferiores
    E.2.2Secondary objectives of the trial
    -Changes and evolution of hemoglobin during admission; difference in hemoglobin (Hb) between inclusion, intervention and discharge. Hb 30 days after discharge
    -Establish the optimal preoperative moment of increased intravenous iron yield to increase Hb
    -Impact of anemia and its treatment on the length of hospital stay, morbidity and mortality and quality of life during admission and first 30 days postoperatively
    -Cambios y evolución de la hemoglobina durante el ingreso; diferencia en la hemoglobina (Hb) entre la inclusión, la intervención y el alta. Hb a los 30 días del alta
    -Establecer el momento preoperatorio óptimo de mayor rendimiento del hierro intravenoso para aumentar la Hb
    -Impacto de la anemia y su tratamiento sobre la duración de la estancia hospitalaria, morbimortalidad y calidad de vida durante el ingreso y primeros 30 días postoperatorios
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients of both sexes over 18 years
    -Patients diagnosed with anemia, considered as , Hb <13.0 g/dL in mens and Hb<12g/dL in women
    -Patients diagnosed with symptomatic chronic lower limb ischemia (degrees 2-5 by Rutherford-Baker, both included, Fontaine II-IV), who will undergo surgical revascularization (endovascular or open) and accept treatment
    - Revascularization surgery scheduled in the approximate minimum period of one week, (> 7 days) from the inclusion
    -They are able and willing to give written informed consent at the time of selection
    -Pacientes de ambos sexos mayores de 18 años
    -Pacientes diagnosticados con anemia, considerada como, Hb <13.0 g/dL en hombres y Hb<12g/dL en mujeres
    -Pacientes diagnosticados de isquemia crónica de miembros inferiores sintomática (grados 2-5 de Rutherford-Baker, ambos incluidos; II-IV de Fon-taine), que vayan a ser sometidos a revascularización quirúrgica (endovascular o abierta) y que acepten el tratamiento
    -Cirugía de revascularización programada en el plazo aproximado mínimo de una semana, (>7 días) desde la inclusión
    -Que sean capaces y estén dispuestos a dar el consentimiento informado por escrito en el momento de la selección
    E.4Principal exclusion criteria
    -Patients with acute ischemia will be excluded
    -Severe anemia < 8 gr/dL
    -Arterial hypertension not controlled with antihypertensive medication (considered with systolic blood pressure> 180mmHg or diastolic> 100mmHg)
    - Acute renal failure or renal failure with creatinine clearance <30mmHg
    -Patient with documented intolerance or allergy to iron or its derivatives
    -Unstable angina, defined as electrocardiographic changes with chest pain that indicate resting myocardial ischemia
    -History of stroke in the previous 6 months
    -Patients with thrombocytopenia less than 50,000ug/dl or alterations in coagulation
    -That you are simultaneously participating in a clinical trial that conditions or modifies the registry
    -Patients already diagnosed with iron-deficiency anemia in oral iron treatment in their usual medication
    -Pregnancy or lactation (pregnancy tests in women of childbearing age according to usual practice)
    -Rejection of treatment or inclusion in the registry by the patient
    -Patients who refuse to receive transfusions of blood products (for example, Jehovah's Witnesses)
    -Patients with criteria of SEPSIS
    -Patients with Ferritin <30 ng/ml that will be directed for digestive study
    -Patients with active neoplasia
    -Patients who are not able to give their informed consent or understand the study procedure
    -Se excluirán los pacientes con isquemia aguda
    -Anemia grave < 8 gr/dL
    -Hipertensión arterial no controlada con la medicación antihipertensiva (considerada con tensión sistólica >180mmHg o diastólica >100mmHg)
    -Fallo renal agudo o insuficiencia renal con aclaramiento de creatinina <30mmHg
    -Paciente con intolerancia o alergia documentada al hierro o sus derivados
    -Angina inestable, definida como cambios electrocardiográficos con dolor torácico que indiquen isquemia miocárdica en reposo
    -Historia de ictus en los 6 meses previos
    -Pacientes con trombocitopenia menor de 50.000ug/dl o alteraciones en la coagulación.
    -Que simultáneamente esté participando en un ensayo clínico que condicione o modifique el registro
    -Pacientes ya diagnosticados de anemia ferropénica en tratamiento con hierro vía oral en su medicación habitual
    -Embarazo o lactancia (pruebas de embarazo en mujeres en edad fértil según práctica habitual)
    -Rechazo del tratamiento o de la inclusión en el registro por parte del paciente
    -Pacientes que se nieguen a recibir transfusiones de hemoderivados (por ejemplo; testigos de Jehovah)
    -Pacientes con criterios de SEPSIS
    -Pacientes con Ferritina <30 ng/mL qué serán dirigidos para estudio digestivo
    -Pacientes con neoplasia activa
    -Pacientes que no sean capaces de dar su consentimiento informado o entender el procedimiento del estudio
    E.5 End points
    E.5.1Primary end point(s)
    Reduce the incidence of transfusion from randomization up to 30 days after the main surgery in patients with anemia who undergo revascularization surgery with chronic lower limb ischemia
    Reducir la incidencia de transfusión desde la randomización hasta 30 días después de la cirugía principal en pacientes con anemia que son sometidos a cirugía de revascularización con isquemia crónica de miembros inferiores
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 months
    18 meses
    E.5.2Secondary end point(s)
    18 months
    18 meses
    E.5.2.1Timepoint(s) of evaluation of this end point
    18 months
    18 meses
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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 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) 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
    The end of the trial it is the last visit of the last subject undergoing the trial
    El final del ensayo es la última visita del último sujeto sometido al ensayo
    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 months0
    E.8.9.1In the Member State concerned days0
    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: 230
    F.1.3Elderly (>=65 years) No
    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 state230
    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)
    If the result are significants the pacient will be treated with the investigational product
    Si los resultados son significativos, el pacientes será tratado con el medicamento ha estudio
    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 Decision2019-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-21
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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