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    Summary
    EudraCT Number:2020-002956-20
    Sponsor's Protocol Code Number:FerinjectFPG2020
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-11-06
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-002956-20
    A.3Full title of the trial
    Prospective, interventional, open-label single center pilot study to evaluate FERInject Efficacy in 20 maintenance kidney transplant recipients.
    Studio FERIE: studio di efficacia del ferro carbossimaltosio nel paziente trapiantato di rene
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective, interventional, open-label single center pilot study to evaluate FERInject Efficacy in 20 maintenance kidney transplant recipients.
    Prospective, interventional, open-label single center pilot study to evaluate FERInject Efficacy in 20 maintenance kidney transplant recipients.
    A.3.2Name or abbreviated title of the trial where available
    FERIE
    FERIE
    A.4.1Sponsor's protocol code numberFerinjectFPG2020
    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 SponsorFONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    B.1.3.4CountryItaly
    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 supportVifor Pharma Group
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDirezione scientifica Fondazione Policlinico A.Gemelli IRCCS
    B.5.2Functional name of contact pointDirezione Scientifica Fondazione Po
    B.5.3 Address:
    B.5.3.1Street AddressLargo Agostino Gemelli 8
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.4Telephone number0630155701
    B.5.5Fax number0630155701
    B.5.6E-maildirezione.scientifica@policlinicogemelli.it
    D. IMP Identification
    D.IMP: 1
    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-GRAD - 105 MG COMPRESSE A RILASCIO PROLUNGATO 40 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderTEOFARMA S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameFERRO-GRAD
    D.3.2Product code [NA]
    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 INNFERRO SOLFATO
    D.3.9.1CAS number 7782-63-0
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number105
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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/ML SOLUZIONE INIETTABILE O PER INFUSIONE 5 FLACONCINI IN VETRO DA 2 ML
    D.2.1.1.2Name of the Marketing Authorisation holderVIFOR FRANCE SA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.2Product code [NA]
    D.3.4Pharmaceutical form Solution for injection
    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 INNFERRO CARBOSSIMALTOSIO
    D.3.9.1CAS number 9007-72-1
    D.3.9.2Current sponsor codeNA
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    This study is aimed at kidney transplant recipient with chronic kidney disease, iron deficiency and anemia.
    Il presente studio è rivolto a pazienti trapiantati di rene con malattia renale cronica, deficit marziale e anemia.
    E.1.1.1Medical condition in easily understood language
    This study is aimed at kidney transplant recipient with chronic kidney disease, iron deficiency and anemia.
    Il presente studio è rivolto a pazienti trapiantati di rene con malattia renale cronica, deficit marziale e anemia.
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10050308
    E.1.2Term Iron replacement
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary: To evaluate Ferric Carboxymaltose efficacy to improve anemic status in post-transplant CKD patients.
    Obiettivo principale del presente studio è valutare la capacità del FCM nel migliorare lo stato anemico in pazienti con CKD trapiantati di rene.
    E.2.2Secondary objectives of the trial
    Secondary: To define a clinical approach for iron supplementation and ESA management in CKD kidney transplant recipients.
    Obiettivo secondario sarà quello di definire un approccio clinico alla supplementazione marziale e alla gestione degli ESA nei pazienti trapiantati di rene con malattia renale cronica.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: TRANSLATIONAL APPROACH TO IRON DEFICIENCY (v 1.0 2020 June 01)
    pag. 5 Protocol

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Approccio Traslazionale alla carenza marziale (v 1.0 2020 June 01)
    pag. 3 Sinossi
    E.3Principal inclusion criteria
    Inclusion criteria for Baseline visit
    1. Age > 18 years
    2. Transplant vintage > 3 months (living or deceased, useful subpopulation)
    3. In active ESA therapy (last ESA dose within 6 weeks before screening)
    4. GFR between 30 and 60 ml/min/1.73 m2 according to CKD-EPI equation
    5. Anemia with hemoglobin between 8-12 g/dl ,
    6. TSAT < 30% and Ferritin < 300 ug/L (6)
    7. Patient able to understanding and sign an informed consent
    Criteri di inclusione alla visita Baseline:
    • Età > 18 anni;
    • Trapianto di rene effettuato da più di 3 mesi;
    • In terapia con ESA attiva (ultima dose somministrata entro 6 settimane dallo screening)
    • GFR tra 30 and 60 ml/min/1.73 m2 secondo la formula CKD-EPI
    • Anemia con emoglobina compresa tra 8-12 g/dl
    • TSAT < 30% e Ferritina < 300 ug/L
    • Paziente in grado di comprendere e firmare il consenso informato
    E.4Principal exclusion criteria
    1. Need for HD
    2. Active bleeding
    3. Recent transfusion (within 30 days before screening) or need for transfusion
    4. Patients currently in therapy with ferric carboxymaltose (last dose within 60 days before screening)
    5. Patient is participating or has participated in another clinical trial and/or is taking or has been taking an investigational drug in the past 30 days before screening.
    6. Patient is unlikely to comply with the visits scheduled in the protocol
    7. Female patients of childbearing potential, which do not want to maintain effective birth control, practice during the study and 3 months thereafter.
    8. Female patients pregnant or during feeding time.
    9. Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication with the investigator.
    10. Known hypersensitivity to iron sulfate, ferric carboxymaltose, foline or one of the excipients.
    11. Evidence of iron overload or excessive accumulation of iron (hemochromatosis, chronic hemolysis)
    12. Disorders of iron metabolism (sideroacrestical anemias, sideroblastic anemia, saturnine anemia, thalassemia).
    13. Anemia not attributable to iron deficiency and CKD, e.g. other microcytic anemia.
    14. Previous adverse events following iron administration.
    15. Patients with LES, Rheumatoid Arthritis, allergic asthma, liver diseases (screening alanine transaminase or aspartate transaminase >3 times the upper limit of the normal range).
    16. Active HIV infection or AIDS syndrome, or active hepatitis B or C virus infection
    17. Active malignancy
    18. Known active infection
    19. C-reactive protein >20 mg/L
    1. Necessità di dialisi
    2. Sanguinamento attivo
    3. Necessità di trasfusione di emazie e o storia recente di trasfusioni (entro 30 giorni prima dello screening)
    4. Paziente attualmente in trattamento con Ferro Carbossimaltosio (ultima dose somministrata 60 giorni prima dello screening)
    5. Paziente già incluso in un altro trial clinico sperimentale o in terapia già con un farmaco sperimentale entro I 30 giorni prima dello screening.
    6. Pazienti non in grado di completare le visite richieste dallo studio
    7. Pazienti di sesso femmine in fase fertile che non accettano di mantenere delle pratiche attive anticoncezionali durante lo studio e nei tre mesi successivi ad esso.
    8. Pazienti incinte o in allattamento al momento delo screening
    9. Pazienti noti per abuso di sostanze e disordini psichiatrici
    10. Nota ipersensibilità al ferro solfato, al ferro carbossimaltosio, alla folina o ad altri eccipienti.
    11. Evidenza di sovraccarico di ferro o altra patologia da accumulo marziale (emocromatosi, emolisi cronica)
    12. Disordini del metabolismo del ferro (anemia sideroblastica e sideroacrestica, anemia saturnina, talassemia).
    13. Anemia non attribuibile a carenza di ferro e malattia renale cronica, ad esempio altre forma di anemia microcitica
    14. Pregressa evento avverso durante somministrazione di ferro
    15. Pazienti con LES, artrite reumatoide, asma allegerica e patologie del fegato
    16. Infezione attiva da HIV, HBV, HCV
    17. Patologia oncologica attiva (meno di 5 anni dalla diagnosi o attualmente in terapia chemioterapica o radioterapica)
    18. Infezione nota attiva
    19. Proteina C Reattiva >20 mg/L
    E.5 End points
    E.5.1Primary end point(s)
    1. Average change in TSAT at 6 months in FCM treatment after non-responsive OIT
    • la variazione media di TSAT nei pazienti trattati con ferro carbossimaltosio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    E.5.2Secondary end point(s)
    1. Number of patients with TSAT >30% after 6 months of FCM treatment
    2. Duration of administration of FCM and ESA to reach Hb levels >10.5 g/dL and <11.5 g/dL
    3. Cumulative ESA dose in 12 weeks
    4. Cumulative dose and frequency of administration of FCM in order to maintain Hb levels > 11.5 g/dL
    5. Cumulative ESA dose in the FCM Treatment period
    6. Cumulative dose of FCM in 12 weeks to reach Hb levels >10,5 g/dL and <11.5 g/dL
    7. Need of blood transfusions
    8. ESA hypo-responsiveness in FCM treatment
    9. GFR slope
    1. Il numero di pazienti con TSAT >30% dopo 6 mesi di terapia con FCM
    2. Le dosi necessarie di FCM e ESA per raggiunge i livelli di emoglobina >10,5 g/dl <11,5 g/dl
    3. La dose cumulativa di ESA a 12 settimane
    4. La dose cumulativa e la frequenza di somministrazione di FCM per mantenere un Hb >11.5g/dl
    5. La dose cumulativa di FCM a 12 settimane per raggiungere livelli di Hb >10,5 g/dl <11,5 g/dl
    6. La necessità di trasfusioni di sangue
    7. Il numero di casi di resistenza al trattamento con ESA durante somministrazione di FCM
    8. Lo slope di GFR
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    pre post
    pre post
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 15
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    BEST CLINICAL PRACTICE
    NORMALE PRATICA CLINICA
    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 Decision2021-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-05
    P. End of Trial
    P.End of Trial StatusOngoing
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