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    Summary
    EudraCT Number:2013-002267-25
    Sponsor's Protocol Code Number:PIVOTAL
    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:2013-07-17
    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 number2013-002267-25
    A.3Full title of the trial
    UK Multicentre Open-label Randomised Controlled Trial Of IV Iron Therapy
    In Incident Haemodialysis Patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Proactive IV irOn therapy for HaemodiALysis patients (PIVOTAL)
    A.3.2Name or abbreviated title of the trial where available
    PIVOTAL
    A.4.1Sponsor's protocol code numberPIVOTAL
    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 SponsorKing's College Hospital NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportKidney Research UK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College Hospital NHS Foundation Trust
    B.5.2Functional name of contact pointProfessor Iain Macdougall
    B.5.3 Address:
    B.5.3.1Street AddressKing's College Hospital, Renal Unit, Denmark Hill
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 9RS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4402032996233
    B.5.5Fax number+4402032996472
    B.5.6E-mailiain.macdougall@nhs.net
    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 Venofer
    D.2.1.1.2Name of the Marketing Authorisation holderVifor Pharma
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 (Venofer)
    D.3.4Pharmaceutical form 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.3.9.4EV Substance CodeAS1
    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 in anaemia of end stage renal disease.
    E.1.1.1Medical condition in easily understood language
    Shortage of iron in the context of end stage kidney failure.
    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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 100000004857
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10066763
    E.1.2Term Chronic iron deficiency anaemia
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10066623
    E.1.2Term Chronic haemodialysis
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10014647
    E.1.2Term End stage renal failure
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the effect of a proactive high-dose, with a reactive low-dose, IV iron regimen on all-cause mortality and the incidence of non-fatal cardiovascular endpoints in haemodialysis patients.
    E.2.2Secondary objectives of the trial
    To determine whether a regimen of proactive IV iron supplementation in haemodialysis patients reduces mortality / cardiovascular endpoints compared to a reactive low-dose regimen.
    To compare the effect of the two regimens on ESA dose requirements, RBC transfusions, complications of haemodialysis treatment, and QoL.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients > or = 18 years
    - Patients established on a chronic haemodialysis programme for end-stage renal failure
    - Clinically stable (Principal Investigator’s judgement)
    -Within 0–12 months since commencing haemodialysis
    -Ferritin < 400 ug/L
    -Transferrin saturation < 30%
    -On ESA (erythropoiesis stimulating agent) therapy
    -Written informed consent
    E.4Principal exclusion criteria
    - Life expectancy < 12 months (Principal Investigator’s judgement)
    - Living-donor transplant scheduled within the next 12 months
    - CRP > 50 mg/L
    - Active infection
    - Current active malignancy (with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia)
    - Known HIV or active hepatitis B or C
    - Chronic liver disease and/or screening alanine transaminase or aspartate transaminase above 3 times the upper limit of the normal range
    - Advanced heart failure (NYHA IV)
    - Pregnancy or breast feeding
    - History of acquired iron overload
    - Previous severe hypersensitivity reactions to IV iron sucrose (Venofer®)
    - Subject has any kind of disorder that compromises their ability to give written informed consent and/or to comply with study procedures
    E.5 End points
    E.5.1Primary end point(s)
    Time to all-cause death or a composite of non-fatal cardiovascular events (myocardial infarction, stroke, and hospitalisation for heart failure) adjudicated by a blinded Endpoint Adjudication Committee.
    E.5.1.1Timepoint(s) of evaluation of this end point
    This is an event-driven trial - the evaluation will only be conducted once the required number of events are accrued (approximately 2-3 years).
    E.5.2Secondary end point(s)
    SECONDARY EFFICACY

    - Incidence of all-cause death and a composite of myocardial infarction, stroke, and hospitalisation for heart failure as recurrent events.
    - Time to (and incidence of) all-cause death
    - Time to (and incidence of) composite cardiovascular event
    - Time to (and incidence of) myocardial infarction
    - Time to (and incidence of) stroke
    - Time to (and incidence of) hospitalisation for heart failure
    - ESA dose requirements
    - Transfusion requirements
    - EQ-5D QOL and KDQOL


    SECONDARY SAFETY

    - Vascular access thrombosis
    - All-cause hospitalisation
    - Hospitalisation for infection
    - Infection episodes
    E.5.2.1Timepoint(s) of evaluation of this end point
    This is an event-driven trial - the evaluation will only be conducted once the required number of events are accrued (approximately 2-3 years).
    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) 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Same IMP but different dose.
    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 concerned35
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2080
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2080
    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 2013-07-17. 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 state2080
    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)
    The patient's dialysis physician will decide on the appropriate dose of intravenous iron supplementation to continue in the future.
    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 Decision2013-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-06
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