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    Summary
    EudraCT Number:2013-000327-14
    Sponsor's Protocol Code Number:1.0
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-09-09
    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 ConcernedAustria - BASG
    A.2EudraCT number2013-000327-14
    A.3Full title of the trial
    High dose intravenous iron in blood donors with iron deficiency: a randomized, controlled trial
    Intravenöse Hochdosis-Eisentherapie bei BlutspenderInnen mit Eisenmangel: eine randomisierte, kontrollierte Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Intravenous application of iron in high dosage in blood donors with iron deficiency: a randomized, controlled trial
    Intravenöse Verabreichung von Eisen in hoher Dosis bei BlutspenderInnen mit Eisenmangel: eine randomisierte, kontrollierte Studíe
    A.3.2Name or abbreviated title of the trial where available
    IronWoMan
    A.4.1Sponsor's protocol code number1.0
    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 SponsorMedizinische Universität Graz, Universitätsklinik für Innere Medizin, Abteilung für Endokrinologie und Stoffwechsel
    B.1.3.4CountryAustria
    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 supportMedizinische Universität Graz, Universitätsklinik für Innere Medizin, Abteilung für Endokrinologie und Stoffwechsel
    B.4.2CountryAustria
    B.4.1Name of organisation providing supportUniversitätsklinik für Blutgruppenserologie und Transfusionsmedizin Graz
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinik für Blutgruppenserologie und Transfusionsmedizin Graz
    B.5.2Functional name of contact pointNazanin Sareban
    B.5.3 Address:
    B.5.3.1Street AddressAuenbruggerplatz 3
    B.5.3.2Town/ cityGraz
    B.5.3.3Post code8036
    B.5.3.4CountryAustria
    B.5.4Telephone number0043316385-83069
    B.5.5Fax number0043316385-13429
    B.5.6E-mailnazanin.sareban@klinikum-graz.at
    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 50 mg iron/ml solution for injection/infusion
    D.2.1.1.2Name of the Marketing Authorisation holderVifor France SA
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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.3.9.3Other descriptive nameIron
    D.3.9.4EV Substance CodeSUB66620
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Ferretab
    D.2.1.1.2Name of the Marketing Authorisation holderG.L. Pharma GmbH, 8502 Lannach
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 Capsule
    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
    D.3.9.1CAS number 141-01-5
    D.3.9.3Other descriptive nameFERROUS FUMARATE
    D.3.9.4EV Substance CodeSUB13865MIG
    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
    One of the most common risks of blood donation is iatrogenic iron deficiency, as each whole blood donation causes a loss of 200 to 250 mg of iron. Within the scope of this trial blood donors are screened for iron deficiency and as a consequence of low iron stores invited to participate in this trial. Parameter for low iron stores is Ferritin and a value below 30 ng/ml is required for inclusion in the study.
    Eine häufige Nebenwirkung von Blutspenden ist ein iatrogener Eisenmangel, weil jede Vollblutspende mit einem Eisenverlust von 200-250 mg einhergeht. Im Rahmen dieser Studie werden Blutspender auf Eisenmangel gescreent und bei niedrigem Eisenspeicher zur Teilnahme an der Studie eingeladen. Als Parameter für entleerte Eisenspeicher dient Ferritin und ein Wert unter 30 ng/ml ist für einen Einschluss in die Studie gefordert.
    E.1.1.1Medical condition in easily understood language
    Iron deficiency is a common risk of blood donation. In this trial iron values are determined in blood donors. If iron deficiency is seen a participation in the trial is suggested.
    Eisenmangel ist eine häufige Nebenwirkung des Blutspendens. In dieser Studie werden Eisenwerte bei Blutspendern bestimmt. Im Falle eines Eisenmangels wird eine Teilnahme an der Studie vorgeschlagen.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this trial is to show, that intravenous high dose iron is an excellent option for the treatment of blood donors with iron deficiency. Because of its high efficacy and feasibility and the resultant optimal compliance with similar safety profile the one time application of high dose iron is superior to oral iron substitution.
    Die Hypothese dieser Studie ist, dass intravenöses Eisen bei BlutspenderInnen mit Eisenmangel eine exzellente Behandlungsoption ist. Bei hoher Wirksamkeit, Praktikabilität und durch die unter anderem daraus resultierende bessere Compliance bei gleicher Produktsicherheit ist die einmalige hochdosierte intravenöse Eisengabe der oralen Eisensubstitution überlegen.
    E.2.2Secondary objectives of the trial
    Not applicable;
    Nicht zutreffend;
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >= 18 years and <= 65 years
    - Ferritin <= 30 ng/ml
    - Fulfilment of the strict criteria for blood donation
    - Alter >= 18 Jahre und <= 65 Jahre
    - Ferritin <= 30 ng/ml
    - Erfüllung der Kriterien der Blutspenderverordnung
    E.4Principal exclusion criteria
    - Hemochromatosis
    - Active infection
    - Pregnancy or lactation
    - History of anaphylaxis to intravenous iron or other substances
    - Signs or symptoms suggestive for acute or chronic gastrointestinal bleeding and/or hypermenorrhoea
    - Hämochromatose
    - Akute Infektion
    - Schwangerschaft und Stillzeit
    - Anaphylaktische Reaktion auf Eisen oder andere Substanzen in der Anamnese
    - Verdacht auf akute oder chronische gastrointestinale Blutungen und/oder Hypermenorrhoe
    E.5 End points
    E.5.1Primary end point(s)
    Transferrin saturation (%) at visit 1 (V1);
    .
    Transferrinsättigung am Ende der Studie (V1);
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 1 (V1)/ End of the study:
    8-10 weeks after intravenous application of high dose iron or after finishing the oral iron substitution therapy
    Visit 1 (V1)/ Ende der Studie:
    8-10 nach Verabreichung des hochdosierten intravenösen Eisenpräparates bzw. nach Beendigung der oralen Eisensubstitution
    E.5.2Secondary end point(s)
    -Other parameters of iron metabolism and red blood count
    -Number of patients with adverse events of different grades
    -Subjective symptoms of iron deficiency, including the restless legs syndrome and fatigue
    -quality of life
    -Andere Parameter des Eisenstoffwechsels und des roten Blubildes
    -Anzahl der Patienten mit Nebenwirkungen unterschiedlichen Schweregrades
    -Subjektive Beschwerden, die mit Eisenmangel einhergehen können, wie Restless Legs Syndrom und Müdigkeit
    -Lebensqualität
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 1 (V1)/ End of the study
    Visit 1 (V1)/ Ende der Studie
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence Yes
    E.6.9Dose response Yes
    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 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 concerned2
    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;
    Visit 1 (V1) des letzten Studienteilnehmers;
    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: 195
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state200
    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;
    Generally no further visits nor treatments will be necessary after finishing the trial.
    If further visits or treatments are indicated, because of for example pathologic laboratory values at the end of the study, they will be carried out by the general practitioner.
    Keine;
    In der Regel wird keine weitere Behandlung der StudienteilnehmerInnen nach Abschluss der Studie erforderlich sein. Falls auf Grund pathologischer Laborwerte am Ende der Studie weitere Kontrollen erforderlich sind, werden die SpenderInnen an den Hausarzt/ die Hausärztin verwiesen.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-24
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