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    Summary
    EudraCT Number:2009-016522-14
    Sponsor's Protocol Code Number:20090160
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-06-09
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2009-016522-14
    A.3Full title of the trial
    A Multicenter, Randomised, Double-blind, Placebo-controlled Study of Darbepoetin alfa for the Treatment of Anaemic Subjects with
    Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
    "Ensayo clínico multicéntrico, randomizado, doble ciego y controlado con placebo de
    darbepoetin alfa para el tratamiento de sujetos anémicos con síndrome mielodisplásico de riesgo
    bajo o intermedio-1"
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An international research study to find out more about darbepoetin alfa in people with Myelodysplastic Syndrome (MDS) and anaemia. This study will see if darbepoetin alfa increases your haemoglobin levels and whether it causes any side effects. To do this, darbepoetin alfa will be compared to placebo. The placebo will look like the darbepoetin alfa but it will not contain any active ingredients. Taking placebo is the same as not taking any medication for your anaemia.
    Es un estudio de investigación internacional para averiguar más acerca de darbepoetin alfa en personas con síndrome mielodisplásico (SMD) y la anemia. Este estudio quiere ver si darbepoetin alfa aumenta sus niveles de hemoglobina y si causa efectos secundarios. Para ello, darbepoetina alfa se compara con un placebo. El placebo se parecerá a darbepoetina alfa, pero no contiene ningún prinicpio activo. Tomar placebo es lo mismo que no tomar ningún medicamento para tratar su anemia.
    A.4.1Sponsor's protocol code number20090160
    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 SponsorAmgen 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 supportAmgen Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ Medical Info – Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, P.O. Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post codeCH-6300
    B.5.3.4CountrySwitzerland
    B.5.6E-mailMedinfoInternational@amgen.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 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 nameDarbepoetin alfa 500 µg
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDARBEPOETIN ALFA
    D.3.9.1CAS number 209810-58-2
    D.3.9.4EV Substance CodeSUB12486MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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) Yes
    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 Yes
    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 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 nameDarbepoetin alfa 300 µg
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDARBEPOETIN ALFA
    D.3.9.1CAS number 209810-58-2
    D.3.9.4EV Substance CodeSUB12486MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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) Yes
    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 Yes
    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 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 nameDarbepoetin alfa 200 µg
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDARBEPOETIN ALFA
    D.3.9.1CAS number 209810-58-2
    D.3.9.4EV Substance CodeSUB12486MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) Yes
    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 Yes
    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: 4
    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 nameDarbepoetin alfa 100 µg
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDARBEPOETIN ALFA
    D.3.9.1CAS number 209810-58-2
    D.3.9.4EV Substance CodeSUB12486MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Yes
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
    síndrome mielodisplásico de riesgo
    bajo o intermedio-1.
    E.1.1.1Medical condition in easily understood language
    Low or Medium Risk Myelodysplastic Syndrome (MDS)
    síndrome mielodisplásico de riesgo
    bajo o intermedio (SMD).
    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 13.1
    E.1.2Level HLT
    E.1.2Classification code 10028536
    E.1.2Term Myelodysplastic syndromes
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the superiority of darbepoetin alfa treatment compared with placebo on the proportion of subjects achieving International Working Group (IWG) erythroid response during the 24-week double-blind treatment period, in anaemic subjects with low or intermediate-1 risk MDS.
    Evaluar la superioridad del tratamiento con Darbepoetin alfa comparado con el tratamiento con placebo en la proporción de sujetos que alcancen respuesta eritroide según el International Working Group (IWG) (Cheson et al., 2006) durante un periodo de tratamiento de 24 semanas con doble ciego en sujetos anémicos con SMD de riesgo bajo o intermedio 1.
    E.2.2Secondary objectives of the trial
    • To assess the superiority of darbepoetin alfa versus placebo on the incidence of RBC transfusion during the double-blind treatment period
    • To assess safety of darbepoetin alfa compared with placebo
    • To assess the health-related qualify of life (HRQOL) scores of darbepoetin alfa compared with placebo, and to assess the effect of haemoglobin change on HRQOL scores
    • Evaluar la superioridad de la Darbepoetin alfa frente al placebo en la incidencia de transfusiones de eritrocitos durante el periodo de tratamiento con doble ciego.
    • Evaluar la seguridad de la Darbepoetin alfa comparada con placebo.
    • Evaluar las puntuaciones de la calidad de vida relacionada con la salud (CVRS) de la Darbepoetin alfa en comparación con el placebo, y evaluar el efecto del cambio de hemoglobina en las puntuaciones de CVRS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Low or intermediate-1 risk MDS patients per IPSS at the time of randomization, as determined by complete blood count (CBC) during screening and bone marrow examination and marrow cytogenetic analysis, performed within 16 weeks prior to randomisation. Subject cannot have been rendered low or intermediate-1 risk by prior disease modifying therapy
    - World Health Organization (WHO) classification of refractory anaemia (RA), refractory anaemia with ring sideroblasts (RARS), refractory cytopenias with multilineage dysplasia (RCMD), MDS unclassified (MDS-U), MDS with isolated del(5q) (5q- syndrome) or refractory anaemia with excess blasts-1 (RAEB-1)
    -Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 assessed during screening
    -Haemoglobin level ≤10.0 g/dL as assessed by the local laboratory; sample obtained within 7 days prior to randomisation (retest during screening is acceptable).
    -Adequate transferrin saturation (Tsat) (≥ 15%) and serum ferritin (≥ 10 ng/mL) as assessed during screening (supplementation and retest during screening is acceptable)
    -Adequate serum folate (≥ 4.5 nmol/L [ ≥2.0 ng/mL]) or RBC folate (≥317 nmol/L [ ≥140 ng/mL]) as assessed by the local laboratory during screening (supplementation and retest during screening is acceptable)
    - Adequate vitamin B12 (≥148 pmol/L ≥200 pg/mL]) as assessed by the local laboratory during screening (supplementation and retest during screening is acceptable)
    -18 years of age or older
    - Subject or subject’s legally acceptable representative has provided informed consent

    -Sujetos con SMD de riesgo bajo o intermedio 1 según IPSS en el momento de la aleatorización, según se determina mediante hemograma completo (HC) durante la selección y de examen de la médula ósea y análisis de la citogenética de la médula realizados dentro de las 16 semanas anteriores a la aleatorización. Los pacientes no pueden haberse vuelto de riesgo bajo o intermedio mediante tratamiento anterior modificador de la enfermedad.
    -Clasificación de la Organización Mundial de la Salud (OMS) de anemia refractaria (AR), anemia refractaria con sideroblastos en anillo (ARSA), citopenias refractarias con displasia multilinaje (CRDM), SMD no clasificado (SMD-NC), SMD con del(5q) aislado (síndrome 5q-) o anemia refractaria con exceso de blastos-1 (AREB-1).
    E.4Principal exclusion criteria
    - Previously diagnosed with intermediate-2 or high risk MDS per IPSS
    - Therapy-related or secondary MDS
    - History of acute leukemia
    - Evidence of bone marrow collagen fibrosis
    - Inherited anaemia, active hemorrhage, red cell aplasia, haemolytic anaemia
    - History of malignancies other than curatively treated non-melanoma skin or in situ carcinoma within 5 years prior to screening
    - History of thrombosis within 6 months prior to randomisation
    - Previous bone marrow or stem cell transplantation
    - Uncontrolled angina, uncontrolled heart failure, or uncontrolled cardiac arrhythmia as determined by the investigator at screening. Subjects with known myocardial infarction within 6 months prior to randomisation.
    - Uncontrolled hypertension as determined by the investigator at screening
    - Clinically significant systemic infection or uncontrolled chronic inflammatory disease
    - History of seizure disorder
    - Previous or ongoing use of ESA therapy, eg, rHuEpo, darbepoetin alfa
    - High transfusion demand: receiving a total of ≥ 4 units of RBC transfusion during either of 2 consecutive 8-week periods
    - Received any RBC transfusion within 14 days prior to randomisation
    - Received cytotoxic chemotherapy for any oncologic indication or planning to receive cytotoxic chemotherapy during the double-blind treatment period of the study
    - Received biologic response modifiers
    - Received myeloablative or craniospinal radiation within 30 days prior to randomisation or planning to receive myeloablative or craniospinal radiation during the double-blind treatment period of the study
    - Received G-CSF therapy within 30 days prior to randomisation or planning to receive G-CSF therapy during the double-blind treatment period of the study
    - Abnormal renal function
    - Abnormal liver function
    - Serum endogenous EPO level > 500 mU/mL at screening
    - Known seropositivity for human immunodeficiency virus (HIV) or diagnosis of Acquired Immunodeficiency Syndrome (AIDS), positive for hepatitis B surface antigen, or seropositive for hepatitis C virus
    - Subjects with active ethanol abuse
    - Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
    - Female subject is not willing to use highly effective contraception during treatment and for at least 1 month after the end of treatment
    - Female subject is pregnant or planning to become pregnant within 1 month after the end of treatment
    - Subject has known sensitivity to any of the products to be administered during dosing
    - Subject has known sensitivity to any of the products to be administered during dosing
    - Subject has previously been randomised into this study
    - Subject will not be available for protocol required study visits, to the best of the subject and investigator’s knowledge
    - Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures
    - Confirmed history of neutralising antibody activity to rHuEpo or darbepoetin alfa
    - Diagnosticado anteriormente con SMD de riesgo intermedio 2 o alto mediante IPSS.
    SMD relacionado con el tratamiento o secundario.
    - Antecedentes de leucemia aguda.
    - Evidencia de fibrosis de colágeno de la médula ósea.
    - Anemia heredada, hemorragia activa, aplasia eritrocitaria, anemia hemolítica.
    - Antecedentes de neoplasias malignas que no sean carcinoma in situ o carcinoma cutáneo no melanoma tratados de forma curativa durante los 5 años anteriores a la selección.

    Antecedentes de trombosis en los 6 meses anteriores a la aleatorización.
    - Trasplante anterior de médula ósea o de células madre.
    - Angina no controlada, insuficiencia cardíaca no controlada, o arritmias cardíacas no controladas según lo determine el investigador en la selección. Sujetos con infarto de miocardio conocido dentro de los 6 meses anteriores a la aleatorización.
    - Hipertensión no controlada, según lo determine el investigador en la selección.
    - Infección sistémica clínicamente significativa o enfermedad inflamatoria crónica no controlada (es decir, artritis reumatoide, enfermedad inflamatoria intestinal) según lo determine el investigador en la selección.
    - Antecedentes de trastornos convulsivos.
    Uso anterior o actual de tratamiento AEE, p. ej., rHuEpo, Darbepoetin alfa.
    - Alta demanda de transfusiones: recibiendo un total de ≥ 4 unidades de transfusiones de eritrocitos durante los 2 periodos consecutivos de 8 semanas (es decir, días -113 a -57 o días -56 a 0) antes de la aleatorización.
    - Que haya recibido cualquier transfusión de eritrocitos dentro de los 14 días anteriores a la aleatorización.
    - Que haya recibido quimioterapia citotóxica para cualquier indicación oncológica o que tenga planeado recibir quimioterapia citotóxica durante el periodo de tratamiento con doble ciego del estudio.
    - Que haya recibido modificadores de la respuesta biológica
    - Que haya recibido radiación mieloablativa o craneoespinal o que tenga planificado recibir radiación mieloablativa o craneoespinal durante el periodo de tratamiento con doble ciego del estudio
    - Que hayan recibido tratamiento con G-CSF durante los 30 días anteriores a la aleatorización
    - Función renal anormal
    - Función hepática anormal
    - Nivel de EPO endógena sérica > 500 mU/ml en la selección
    - Positividad conocida para el virus de la inmunodeficiencia humana (VIH) o diagnóstico de síndrome de inmunodeficiencia adquirida (SIDA), positivo para el antígeno de superficie de la hepatitis B, o seropositivo para el virus de la hepatitis C.
    - Sujetos con abuso activo de etanol, según lo juzgue el investigador.
    Que estén actualmente incluidos en otro estudio de investigación de fármaco o producto sanitario, o menos de 30 días desde la finalización de otros estudios de investigación de fármaco o producto sanitario, o que estén recibiendo otros agentes en investigación.
    - Sujetos mujeres que no deseen utilizar medios anticonceptivos altamente eficaces durante el tratamiento y durante al menos 1 mes después de la finalización del tratamiento.
    - Mujeres que estén embarazadas o que tengan pensado quedar embarazadas dentro del mes siguiente al final del tratamiento.
    - Sujetos que tengan conocida sensibilidad a cualquiera de los productos a ser administrados en la posología.
    - Sujetos que hayan sido aleatorizados previamente en este estudio.
    - Sujetos que no vayan a estar disponibles para las visitas del estudio que requiere el protocolo, según sea el conocimiento del sujeto y del investigador.
    - Sujetos que tengan cualquier trastorno, que, según la opinión del investigador, pueda comprometer la capacidad del sujeto de otorgar consentimiento informado por escrito y/o de cumplir con todos los procedimientos del estudio requeridos.
    - Antecedentes confirmados de actividad de anticuerpos neutralizante para rHuEpo o Darbepoetin alfa.


    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects achieving an IWG erythroid response during the double-blind treatment period. IWG erythroid response for non-transfusion dependent subjects is defined as achieving an initial ≥ 1.5 g/dL increase from baseline in haemoglobin level and sustaining an average rise of ≥ 1.5 g/dL in a rolling 56- consecutive day period in the absence RBC transfusion. IWG erythroid response will be determined based on central laboratory haemoglobin values.
    proporción de sujetos que alcanzan una respuesta eritroide del IWG durante el periodo de tratamiento con doble ciego.
    La respuesta eritroide del IWG para sujetos no dependientes de transfusión se define como alcanzar un aumento inicial de ≥ 1,5 g/dl desde el inicio en el nivel de hemoglobina y mantener un aumento promedio de ≥ 1,5 g/dl en un periodo consecutivo de 56 días con ausencia de transfusiones de eritrocitos.
    La respuesta eritroide del IWG se determinará según los valores de hemoglobina del laboratorio central.
    E.5.1.1Timepoint(s) of evaluation of this end point
    n/a
    E.5.2Secondary end point(s)
    Incidence of at least one RBC transfusion from week 5 to the end of the double-blind treatment period (EOTP)
    Incidencia de al menos 1 transfusión de eritrocitos desde la semana 5 hasta la finalización del periodo de tratamiento doble ciego.
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    última visita del último sujeto incluido en el ensayo
    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 days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 0
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 144
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 180
    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)
    As per the protocol
    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 Decision2011-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-09-22
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