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    Summary
    EudraCT Number:2019-002195-14
    Sponsor's Protocol Code Number:KPPM-Hx
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-05
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-002195-14
    A.3Full title of the trial
    Randomized clinical trial to assess the monocitary functionality and their relationship with the administration of intravenous iron in patient in hemodialysis according to practice guidelines or according to expert recommendations.
    ENSAYO CLÍNICO ALEATORIZADO PARA EVALUAR LA FUNCIONALIDAD MONOCITARIA EN RELACIÓN CON EL TRATAMIENTO CON HIERRO IV EN PACIENTES EN HEMODIÁLISIS SEGÚN GUÍAS DE PRÁCTICA CLÍNICA O SEGÚN RECOMENDACIONES DE EXPERTOS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized clinical trial to compare the administration of intravenous iron in patient in hemodialysis according to practice guidelines or according to expert recommendations.
    Ensayo clínico aleatorizado para comparar la administración de hierro intravenoso siguiendo las guías de práctica clínica o siguiendo las recomendaciones de expertos.
    A.4.1Sponsor's protocol code numberKPPM-Hx
    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 SponsorUniversity Hospital "Príncipe de Asturias"
    B.1.3.4CountrySpain
    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 supportUniversity Hospital "Príncipe de Asturias"
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital "Príncipe de Asturias"
    B.5.2Functional name of contact pointKorina
    B.5.3 Address:
    B.5.3.1Street AddressCrta. Alcalá-Meco
    B.5.3.2Town/ cityAlcalá de Henares
    B.5.3.3Post code28805
    B.5.3.4CountrySpain
    B.5.4Telephone number+349188781004097
    B.5.6E-mailkorinapenae@yahoo.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 Feriv
    D.2.1.1.2Name of the Marketing Authorisation holderGES
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 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, parenteral preparations
    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
    Monocyte function in patients with anemia in hemodialysis
    Funcionalidad monocitaria en pacientes con anemia en hemodiálisis
    E.1.1.1Medical condition in easily understood language
    Anemia in patients in hemodialysis
    Anemia en pacientes en hemodiálisis
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10002272
    E.1.2Term Anemia
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027884
    E.1.2Term Monocytes
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10005671
    E.1.2Term Blood monocytes normal
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10005669
    E.1.2Term Blood monocytes decreased
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10027881
    E.1.2Term Monocyte count low
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10027879
    E.1.2Term Monocyte count high
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess if the administration of intravenous iron,based only in levels of transferrin saturation index, does not generate relevants changes (higher than 15%) in the proportion of monocytes (CD14+ and CD16+) compared with patients that received treatment with intravenous iron according to the practice guidelines in place.
    Evaluar si la administración de hierro i.v. basada únicamente en el índice de saturación de la transferrina, no condiciona cambios relevantes, superiores al 15 %, en la proporción de monocitos CD14+ y CD16+, en comparación con los pacientes tratados según las guías clínicas vigentes en la actualidad.
    E.2.2Secondary objectives of the trial
    Evaluate:
    . The mortality rate of patients in 2 years-interval.
    - The number and severity of infections in 2 years-interval.
    - The mean haemoglobin levels
    - Number of Erythropoiesis-stimulating agents administered and blood transfusions.
    - The iron build up in liver tissue measured by magnetic resonance (NMR), as well as the hepatocellular function
    - The iron accumulates in serum monocytes.
    Evaluar:
    - La mortalidad de los pacientes en el intervalo de 2 años.
    - El número y la severidad de los episodios infecciosos, cuantificada según la estancia hospitalaria, en el intervalo de 2 años.
    - Los niveles medios de hemoglobina durante todo el periodo, así como los niveles totales de agentes estimuladores de la eritropoyesis y transfusiones administradas.
    - La acumulación de hierro en tejido hepático medida mediante resonancia magnética (RMN), realizada anualmente, así como la función hepatocelular.
    - El grado de acumulación de hierro en el sistema retículo-endotelial fagocítico, medido por el acúmulo de hierro en células mononucleadas circulantes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Older than 18.
    - Hemodialysis indicence patients (between 2 and 6 months in hemodialysis).
    - Having signed the inform consent.
    - Patients with anemia who require intravenous iron
    - Have not received intravenous iron before hemodialysis.
    - Clinically stable.
    -Pacientes incidentes en programa de hemodiálisis, con más de 2 meses de tratamiento con hemodiálisis y menos de 6 meses en hemodiálisis mantenida.
    - Edad mayor de 18 años.
    - Haber firmado el consentimiento informado.
    - Pacientes con anemia susceptible de ser tratada con hierro i.v. con objetivo de índice de saturación de la transferrina del 30%
    - No haber recibido hierro i.v. antes del inicio de hemodiálisis.
    - Pacientes clínicamente estables, con una expectativa de vida superior a 2 años.
    E.4Principal exclusion criteria
    - Patients with a ferritin level higher than 500mg/dl
    - Patients who have exceeded transferrin levels in the prior year to be included in the clinical trial.
    - Patients who, before the hemodialysis, had received intravenous iron.
    - Patients with chronic HIV or hepatitis C infection.
    - Pregnant women or breastfeeding period
    - Pacientes con niveles de ferritina >500 mg/dl al inicio del estudio.
    - Pacientes que hayan superado niveles de ferritina >500 mg/dl en el año previo a su inclusión en el estudio
    - Pacientes que hayan recibido hierro i.v. antes del inicio de hemodiálisis.
    - Pacientes embarazadas o en período de lactancia.
    - Pacientes con infección crónica por VHC y VHB.
    E.5 End points
    E.5.1Primary end point(s)
    Serum monocyte
    Nivel de monocitos
    E.5.1.1Timepoint(s) of evaluation of this end point
    Monthly for 2 years period.
    mensualmente en el periodo de 2 años.
    E.5.2Secondary end point(s)
    Mortality and number of infections.
    Mortalidad y número de infecciones.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 years
    2 años
    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 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 Yes
    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 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 No
    E.8.2.4Number of treatment arms in the trial2
    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.8.5The 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
    - Whenever the risk/benefit balance, of the experimental group vs the control group, were unfavourable.
    - At the discretion of the sponsor
    - Ultima visita del último paciente incluido.
    - Cuando por razones de seguridad se detecte una relación beneficio-riesgo desfavorable del grupo experimental frente a lo establecido en las guías de práctica clínica.
    - A criterio del promotor.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state58
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 58
    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)
    Clinical practice
    Práctica clínica habitual.
    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 Decision2019-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-22
    P. End of Trial
    P.End of Trial StatusOngoing
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