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    Summary
    EudraCT Number:2012-003914-15
    Sponsor's Protocol Code Number:Studienprotokoll/V5.1/01.12.2013
    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:2014-05-27
    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 ConcernedAustria - BASG
    A.2EudraCT number2012-003914-15
    A.3Full title of the trial
    Continuos versus periodic intravenous iron supplementation in maintenance hemodialysis patients
    Kontinuierliche versus periodische intravenöse Eisentherapie bei chronischen Hämodialysepatienten
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Continuos versus periodic intravenous iron supplementation in maintenance hemodialysis patients
    Kontinuierliche versus periodische intravenöse Eisentherapie bei chronischen Hämodialysepatienten
    A.4.1Sponsor's protocol code numberStudienprotokoll/V5.1/01.12.2013
    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 Wien, Klinik für Innere Medizin III, Klin. Abteilung für Nephrologie und Dialyse
    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 Wien, Klinik für Innere Medizin III, Klin. Abteilung für Nephrologie und Dialyse
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Wien, Klinik für Innere Medizin III, Klin. Abteilung für Nephrologie und Dialyse
    B.5.2Functional name of contact pointNephrologie und Dialyse
    B.5.3 Address:
    B.5.3.1Street AddressWähringer Gürtel 18-20
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number+43014040043910
    B.5.5Fax number+43014040043920
    B.5.6E-mailgere.sunder-plassmann@meduniwien.ac.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
    D.2.1.1.2Name of the Marketing Authorisation holderVifor France SA, Neuilly-sur-Seine, Frankreich
    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.3.1Product nameFerinject
    D.3.4Pharmaceutical form Concentrate for solution for injection/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/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 Venofer
    D.2.1.1.2Name of the Marketing Authorisation holderVifor France SA, Neuilly-sur-Seine, Frankreich
    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.3.1Product nameVenofer
    D.3.4Pharmaceutical form Concentrate for solution for injection/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.3.9.3Other descriptive nameIRON SUCROSE
    D.3.9.4EV Substance CodeSUB16439MIG
    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) 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 and iron deficiency in patients with end-stage renal disease on maintenance dialysis
    Anämie und Eisenmangel bei Patienten mit terminaler dialysepflichtiger Niereninsuffizienz
    E.1.1.1Medical condition in easily understood language
    Anemia and iron deficiency in patients with end-stage renal disease on maintenance dialysis
    Anämie und Eisenmangel bei Patienten mit terminaler dialysepflichtiger Niereninsuffizienz
    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
    Ferric carboxymaltose (Ferinject) in comparison to iron sucrose (Venofer) is non inferior in maintaining the target hemoglobin-level (Hb 10-12 g/dl)
    Eisencarboxymaltose (Ferinject) ist der Eisensaccharose (Venofer) nicht unterlegen im Erhalten der Ziel-Hämoglobinspiegel (Hb 10-12 g/dl)
    E.2.2Secondary objectives of the trial
    Ferritin, transferrin, transferrin saturation, consumption of erythropoiesis-stimulating agent (ESA)
    Ferritin, Transferrin, Transferrinsättigung, Verbrauch an Erythropoese-stimulierendem Agens (ESA)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients with anemia and end-stage renal disease on maintenance hemodialysis
    • Hemoglobin ≥ 8,5 g/dl
    • Ferritin < 1000 mg/dl
    • TSAT < 50%
    • CRP < 5 mg/dl
    • Age> 18 years
    • Written informed consent
    • PatientIn mit Anämie und terminaler dialysepflichtiger Niereninsuffizienz
    • Hämoglobin ≥ 8,5 g/dl
    • Ferritin < 1000 mg/dl
    • TSAT < 50%
    • CRP < 5 mg/dl
    • Alter > 18 Jahre
    • Unterschriebene schriftliche Einverständniserklärung vorliegend
    E.4Principal exclusion criteria
    • Hemoglobin < 8,5 g/dl
    • Pregnancy and nursing period
    • Prior allergic reaction on intravenous iron therapy or known allergy on ingredients of the IMP
    • Chronic infectious disease (HIV, Hep B, Hep C)
    • Malignant tumor disease
    • Active infection (CRP > 5 mg/dl, antibiotic treatment – except prophylactic antibiotic treatment)
    • Patients on oral iron therapy at study inclusion
    • Simultaneous participation in another clinical trial
    • Active bleeding
    • Surgical treatment within four weeks prior study inclusion
    • Mental disorder
    • Blood transfusion within four weeks prior study inclusion
    • Drug or alcohol abuse
    • Asthma bronchiale
    • Atopic disease
    • Eczema
    • Hämoglobin < 8,5 g/dl
    • Schwangerschaft, Stillzeit
    • Bekannte allergische Reaktion auf i.v. Eisengabe, bzw. Bestandteile der Prüfsubstanz
    • Chronische Infektion (HIV, Hep B, Hep C)
    • Maligne Tumorerkrankung
    • Aktive Infektion (CRP > 5 mg/dl, Antibiotikatherapie – ausgenommen prophylaktische Antibiotika-Therapie)
    • Orale Eisensubstitution zum Studieninklusionszeitpunkt
    • Zeitgleiche Teilnahme an einer anderen Studie
    • Aktive Blutung
    • Chirurgische Intervention innerhalb der letzten 4 Wochen vor Studieninklusion
    • Psychische Erkrankung
    • Erythrozytenkonservengabe innerhalb der letzten 4 Wochen vor Studieninklusion
    • Drogen-, Alkoholabusus
    • Asthma bronchiale
    • Atopische Allergie
    • Ekzem
    E.5 End points
    E.5.1Primary end point(s)
    Hemoglobin
    Hämoglobin
    E.5.1.1Timepoint(s) of evaluation of this end point
    Study week 40
    Studienwoche 40
    E.5.2Secondary end point(s)
    Ferritin, transferrin, transferrin saturation, consumption of erythropoiesis-stimulating agent (ESA)
    Ferritin, Transferrin, Transferrinsättigung, Verbrauch an Erythropoese-stimulierendem Agens (ESA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Study week 40
    Studienwoche 40
    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 No
    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) 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 Yes
    E.8.1.7.1Other trial design description
    non-inferiority
    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
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2014-05-27. Yes
    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 state140
    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)
    After the subject has ended the participation in the trial the patient will continue to stay in medical care as a maintenance-hemodialysis patient
    Nach Beendigung der Teilnahme an der Klinischen Prüfung wird der Patient weiterhin regelmäßig als chronischer Hämodialysepatient im jeweiligen Dialysezentrum medizinisch betreut.
    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 Decision2014-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-05-14
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