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    Summary
    EudraCT Number:2017-003439-12
    Sponsor's Protocol Code Number:TMP-0916_03
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-11-16
    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 ConcernedGermany - BfArM
    A.2EudraCT number2017-003439-12
    A.3Full title of the trial
    Safety and efficacy of postoperative i.v. iron substitution with Polyglucoferron compared to Ferric Carboxymaltose and oral iron in patients with diagnosed iron deficiency who develop anaemia peri- or postoperatively (IDA II)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to demonstrate safety and efficacy of an intravenous (i.v.) administration of Feramyl compared to i.v. Ferinject and to iron tablets in patients with iron deficiency diganosis before a planned operation who develop anaemia during or after surgery
    A.4.1Sponsor's protocol code numberTMP-0916_03
    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 SponsorFraunhofer Gesellschaft for its Institute Fraunhofer for Molecular Biology and Applied Ecology (IME)
    B.1.3.4CountryGermany
    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 supportiron4u Aps
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFraunhofer IME, Translational Medicine and Pharmacology
    B.5.2Functional name of contact pointProject group TMP
    B.5.3 Address:
    B.5.3.1Street AddressTheodor-Stern-Kai 7
    B.5.3.2Town/ cityFrankfurt am Main
    B.5.3.3Post code60596
    B.5.3.4CountryGermany
    B.5.4Telephone number+49(0)696301 80221
    B.5.5Fax number+4924160855 0040
    B.5.6E-mailClinicalResearch@ime.fraunhofer.de
    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 No
    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 nameFeramyl
    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 (III) hydroxide hydroxyethyl starch glucoheptonic acid complex
    D.3.9.1CAS number CAS 15
    D.3.9.3Other descriptive nameIRON(III) HYDROXIDE POLY(O-2-HYDROXYETHYL) STARCH GLUCOHEPTONIC ACID COMPLEX
    D.3.9.4EV Substance CodeSUB179043
    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 Ferinject
    D.2.1.1.2Name of the Marketing Authorisation holderVifor France SA
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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/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: 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.2.1.1.1Trade name ferro sanol duodenal mite 50 mg
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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, hard
    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 (II) GLYCINE SULFATE COMPLEX
    D.3.9.1CAS number 14729-84-1
    D.3.9.3Other descriptive nameFERROUS (II) GLYCINE SULFATE COMPLEX
    D.3.9.4EV Substance CodeSUB26615
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.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
    pre-operative iron deficiency in patients with planned elective non-cardiac surgery and peri-/post-operative iron deficiency
    E.1.1.1Medical condition in easily understood language
    iron deficiency in patients with planned elective non-cardiac surgery and per-/post-operative iron anaemia
    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 10022974
    E.1.2Term Iron deficiency 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
    1) To demonstrate superiority of i.v. iron substitution with Polyglucoferron compared to oral iron therapy with Ferrous sulfate in focus on proportion of patients who achieve normalized Hb-levels (according to WHO definition) or increased Hb-level with at least 1.5 g/dl 28 days at visit 4 compared to BL

    2) To demonstrate superiority in short term safety assessed of statistically significant lower levels of volume-corrected urine iron, estimated by the difference in v.c. iron urine measured before and after i.v. administration (first urine after the end of i.v. administration) of Polyglucoferron compared to Ferric Carboxymaltose
    E.2.2Secondary objectives of the trial
    •Treatment effects on changes in haematologic and serologic iron parameters (Hb,TSAT,s-iron,s-transferrin,s-ferritin) from BL until V4
    •Proportion of patients with normalization (WHO) of Hb at V4
    •Treatment effects of Polyglucoferron i.v. and Ferric Carboxymaltose i.v. on s-phosphate levels at V4
    •Overall tolerability and number, incidence, seriousness, severity and relationship of AEs/SAEs until 30d after last IMP
    •Changes in laboratory parameters, vital signs and physical exam on each visit incl. blood pressure and heart rate
    •AEs related to injection/infusion site reactions (i.v. groups) and hypersensitivity reactions
    •All-cause mortality until V4
    •The need of allogenic RBC transfusion (number of units and number of patients) from BL until V4
    •Treatment effect on change in Quality of Life (SF-36) at V4 compared to BL
    •Duration of hospital stay (days) until V4
    •Analysis of total iron levels in plasma at BL after end of iron administration (for i.v. safety analysis group)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female; aged ≥ 18 years
    • Patients after major surgery (e.g., orthopaedic/trauma, vascular, visceral, cardiac surgery) with risk of Hb reduction and/or blood loss who develop relevant anaemia defined as haemoglobin of <12 g/dL for female and <13 g/dL for men within 12 to 72 h after start of surgery and with confirmation at Baseline
    • Confirmed and documented preoperative iron deficiency defined as S-ferritin <100 ng/mL without anaemia (Hb ≥12 g/dL for female and ≥13 g/dL for male) within 28 days before surgery
    • need for fast iron replenishment as judged by the treating physician
    • Written informed consent; willing / able to comply with the protocol
    E.4Principal exclusion criteria
    • Pregnancy in female patients or breastfeeding women
    • Female patients not willing to use a safe method of contraception (PEARL index <1) for the full study period
    • Severe physical inability, e.g., ASA physical status IV or V
    • Patients receiving blood transfusion 24 week prior surgery
    • Non-iron deficiency anaemia, e.g., known Vitamin B12 or folate deficiency, haemoglobinopathy, or unexplained anaemia
    • Anticipated medical need for erythropoesis-stimulating agents during the main study period
    • Patients with hemodynamic instability due to any ongoing bleeding. Absence of ongoing bleeding will be confirmed either by decision of two independent physicians or by removal of drainage, whichever occurs earlier in routine care
    • Patients with any contraindication to the investigational products, e.g.,
    o known sensitivity to iron or an ingredient of the investigational products
    o Significant history of systemic allergic reactions
    o Haemachromatosis, thalassemia or TSAT >50% as indicator of iron overload
    o Acute or chronic intoxication
    o Infection (patient on non-prophylactic antibiotics)
    o Chronic liver disease and/or screening ALT or AST above three times the upper limit of the normal range
    • Chronic kidney disease, defined as GFR <30 mL/min
    • Immune-mediated diseases such as rheumatoid arthritis or inflammatory bowel disease if active and uncontrolled
    • Primary haematologic disease
    • Drug or alcohol abuse according to WHO definition
    • Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study
    • Current or previous participation in another clinical trial during the last 90 days before screening

    Exclusion criteria related to Ferrous sulfate:
    • according to SmPC
    • hypersensitivity to any ingredient in the formulation
    • concomitant parenteral iron
    • haemochromatosis, and other iron overload syndromes

    Exclusion criteria related to Ferric Carboxymaltose:
    • according to SmPC
    • hypersensitivity to the active substance, to Ferric Carboxymaltose or any of its excipients
    • known serious hypersensitivity to other parenteral iron products
    • anaemia not attributed to iron deficiency
    • evidence of iron overload or disturbances in the utilisation of iron

    Exclusion criteria related to Polyglucoferron:
    • hypersensitivity to any ingredient in the formulation
    • known serious hypersensitivity to other parenteral iron products
    • anaemia not attributed to iron deficiency
    • evidence of iron overload or disturbances in the utilisation of iron
    E.5 End points
    E.5.1Primary end point(s)
    1) Proportion of patients who achieve normalized Hb-levels or increased Hb of at least 1.5 g/dl in the Polyglucoferron i.v. arm compared to oral iron substitution with Ferrous sulfate at visit 4 compared to BL

    2) Pre-post difference of volume-corrected urine iron levels measured before and in the first urine after the end of i.v. administration, defined as short term safety surrogate marker after administration of the i.v. treatments, compared between Polyglucoferron and Ferric Carboxymaltose (volume corrected iron urine is defined as the ratio between urine iron and urine creatinine).
    E.5.1.1Timepoint(s) of evaluation of this end point
    BL/V2 and V4
    E.5.2Secondary end point(s)
    Secondary endpoints for efficacy:
    • Proportion of patients with normalization (defined in WHO classification) of Hb at visit 4
    • Mean change in Hb, TSAT, s-iron, s-transferrin and s-ferritin until visit 4

    Secondary endpoints for safety:
    • Mean change in s-phosphate levels at visits 4 (i.v. groups only)
    • Overall tolerability and number, incidence, seriousness, severity, relationship of AEs/SAEs until 30 days after last IMP administration
    • Changes in laboratory parameters, vital signs, and physical exam on each visit including blood pressure and heart rate
    • AEs related to injection/ infusion site reactions (i.v. treatment arms only) and hypersensitivity reactions
    • All-cause mortality until visit 4
    Exploratory efficacy endpoints:
    • Proportion of units of allogenic red blood cell transfusion from BL until visit 4
    • treatment effect on Quality of Life (SF36) at visit 4 compared to BL
    • Duration of hospital stay (days) until visit 4
    • Analysis of total iron levels in plasma at BL after end of iron administration [for the i.v. groups (safety analysis group) only]
    E.5.2.1Timepoint(s) of evaluation of this end point
    BL/V2, V3 and V4
    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) 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.8.2.4Number of treatment arms in the trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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 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
    closure of last study site
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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: 204
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 203
    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 state306
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 101
    F.4.2.2In the whole clinical trial 407
    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
    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 Decision2018-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-15
    P. End of Trial
    P.End of Trial StatusOngoing
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