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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2010-022133-28
    Sponsor's Protocol Code Number:AMAG-FER-CKD-401
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-05-17
    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 ConcernedUK - MHRA
    A.2EudraCT number2010-022133-28
    A.3Full title of the trial
    Ferumoxytol for Anemia of CKD Trial (FACT): A Phase IV, Open-Label, Multicenter Trial, with MRI Substudy, of Repeated Doses of Ferumoxytol Compared with Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA) in Chronic Kidney Disease (CKD) Patients on Hemodialysis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial comparing Ferumoxytol with Iron Sucrose for the treatment of Iron Deficiency Anaemia resulting from a lack of stored iron, in adult patients with reduced kidney function.
    A.4.1Sponsor's protocol code numberAMAG-FER-CKD-401
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01227616
    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 SponsorAMAG Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAMAG Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAMAG Pharmaceuticals Inc.
    B.5.2Functional name of contact pointFACT Study Info
    B.5.3 Address:
    B.5.3.1Street Address1100 Winter St.
    B.5.3.2Town/ cityWaltham
    B.5.3.3Post codeMA 02451
    B.5.3.4CountryUnited States
    B.5.6E-mailfactstudyinfo@amagpharma.com
    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 Feraheme
    D.2.1.1.2Name of the Marketing Authorisation holderAMAG Pharmaceuticals, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameferumoxytol
    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 INNFERUMOXYTOL
    D.3.9.1CAS number 722492-56-0
    D.3.9.3Other descriptive nameFERUMOXYTOL
    D.3.9.4EV Substance CodeSUB31284
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameIron Sucrose
    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 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
    Iron Deficiency Anemia (IDA) in Chronic Kidney Disease (CKD) Patients on Hemodialysis
    E.1.1.1Medical condition in easily understood language
    Iron deficiency anaemia resulting from a lack of stored iron, in adult patients with reduced kidney function.
    E.1.1.2Therapeutic area Body processes [G] - Chemical Phenomena [G02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    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
    To demonstrate that 1.02 g courses of ferumoxytol (delivered as either an undiluted IV injection or diluted IV infusion of 510 mg each) are noninferior to 1.0 g courses of iron sucrose (delivered either as slow IV undiluted injections or IV diluted infusions of 100 mg each) in raising hemoglobin after each treatment period in hemodialysis-dependent CKD subjects with IDA over a one-year period
    E.2.2Secondary objectives of the trial
    Main Study:
    To evaluate the safety of repeat doses of ferumoxytol compared to iron sucrose for the treatment of IDA over a one-year period in subjects with hemodialysis-dependent CKD
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Oxidative Stress Substudy:
    The primary objective of the Oxidative Stress Substudy is to evaluate changes in blood biomarkers of oxidative stress/inflammation during the initial Treatment Period (TP) of the Main Study.

    MRI Substudy (AMAG-FER-CKD-401-MRI):
    The objectives of the MRI Substudy are to assess the potential for deposition of iron in cardiac, hepatic, and pancreatic tissues and changes in laboratory parameters over a two-year period
    Primary Objective:
     To assess change from Baseline in cardiac iron deposition as determined by cardiac magnetic resonance imaging (MRI) T2* approximately 6, 12, and 24 months following initial dosing (TP Day 1 in the Main Study)
    Secondary Objectives:
     To assess change from Baseline in hepatic and pancreatic iron deposition as determined by MRI T2* approximately 6, 12, and 24 months following initial dosing
     To assess change from Baseline in ferritin levels, TSAT, liver function tests, thyroid function tests, blood glucose, and Hemoglobin A1c approximately 6, 12, and 24 months following initial dosing
    E.3Principal inclusion criteria
    1. Males and females ≥18 years of age
    2. Subjects with IDA defined as:
    a) hemoglobin <11.5 g/dL; and
    b) transferrin saturation (TSAT) <30%
    3. Serum ferritin <800 ng/mL
    4. Subjects must have been on hemodialysis for at least 3 months prior to Screening
    5. Female subjects of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to Screening and agree to remain on birth control until completion of the study
    6. Subject is capable of understanding and complying with the protocol requirements and available for the duration of the study
    7. Subject has been informed of the investigational nature of this study and has given voluntary written informed consent and, if applicable, Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional, local, and national personal health data protection guidelines
    E.4Principal exclusion criteria
    Main Study:
    1. History of allergy to either oral or IV iron
    2. Female subjects who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test
    3. Parenteral iron therapy within 30 days prior to Screening or red blood cell (RBC)/whole blood transfusion within 14 days prior to Screening or planned during the study
    4. Untreated vitamin B12 or folate deficiency
    5. Erythropoiesis-stimulating agent (ESA) therapy initiated, stopped, or dose changed by >20% within 30 days prior to Screening, or an anticipated ESA dose change of >20% during the initial TP
    6. Received an investigational agent within 30 days prior to Screening, or planned receipt of an investigational agent not specified by this protocol during the study period
    7. Any other clinically significant medical disease or psychiatric disease or condition (eg, active malignancy, uncontrolled hypertension, acute medical illness/infection, psychosis) or subject responsibility that, in the Investigator’s opinion, may interfere with the subject’s ability to give informed consent or adhere to the protocol, interfere with assessment of the study agent, or serve as a contraindication to the subject’s participation in the study
    MRI Substudy:
    Additional exclusion criteria for subjects in the MRI Substudy include:
    1. Has any contraindication to MR imaging, or otherwise unable to undergo MRI (e.g., pacemaker, recent wound clips, severe claustrophobia, unable to lay flat for sufficient time to undergo imaging)
    2. Baseline cardiac T2* value < 20 ms
    E.5 End points
    E.5.1Primary end point(s)
    Main Study:
    Primary Efficacy Endpoint:
     Mean hemoglobin change from Baseline to Week 5 for each TP

    MRI Substudy:
    Primary Endpoint:
     Absolute change in cardiac T2* from Baseline to each follow up evaluation
    E.5.1.1Timepoint(s) of evaluation of this end point
    Main Study:
    Baseline to week 5 for each treatment period

    MRI Substudy:
    Baseline, 6, 12 and 24 months
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
     Mean change in TSAT from TP Baseline to Week 5 for each TP
     Proportion of subjects with an increase in hemoglobin of ≥1.0 g/dL at any time from TP Baseline to Week 5 for each TP
    Exploratory Efficacy Endpoints:
     Time to subsequent treatment courses of ferumoxytol or iron sucrose
     Cumulative IV iron exposure per subject over the course of the study
     Proportion of subjects requiring blood transfusion
     Proportion of subjects who had a change in ESA dose over the course of the study
    Safety Endpoints:
     An evaluation of the AE profile (specific endpoints outlined below) over the course of the study and following each course of ferumoxytol or iron sucrose
    o Serious AEs (SAEs)
    o AEs leading to study drug discontinuation
    o All AEs; vital signs (blood pressure, heart rate, respiration rate, and body temperature); physical examination findings; and routine laboratory parameters (hematology, serum chemistry, and iron panel)

    Oxidative Stress Substudy:
    The Exploratory Safety Endpoints are the mean change from Baseline to Week 5 of the initial TP in the Main Study in blood biomarkers of oxidative stress/inflammation.

    MRI Substudy:
    Secondary Endpoints:
     Proportion of subjects who develop cardiac T2* value <20ms at any time point
     Proportion of subjects who develop cardiac T2* value <10ms at any time point
     Change in Liver Iron Concentration (LIC) as determined by T2* from Baseline to each follow up evaluation
     Change in pancreatic T2* from Baseline to each follow up evaluation
     Change in mean ferritin, TSAT, Liver Function Tests (LFTs) and Thyroid Function Tests (TFTs) values from Baseline to each follow up evaluation
     Change in blood glucose and Hemoglobin A1c from Baseline to each follow up evaluation
    E.5.2.1Timepoint(s) of evaluation of this end point
    Main Study:
    Baseline to week 5 for each treatment period

    MRI Substudy:
    Baseline, 6, 12 and 24 months
    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 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) 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 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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    United Kingdom
    United States
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 300
    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 Decision2013-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-02-24
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