Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2007-004146-32
    Sponsor's Protocol Code Number:AFX01-13
    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:2008-01-02
    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 number2007-004146-32
    A.3Full title of the trial
    AFX01-13: Estudio en fase III, aleatorizado, con control activo, de etiqueta abierta y multicéntrico para evaluar la seguridad y eficacia de la inyección de AF37702 para la corrección de la anemia en pacientes con insuficiencia renal crónica (IRC), no dializados y no tratados con agentes estimuladores de la eritropoyesis (AEE)

    AFX01-13: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of AF37702 Injection for the Correction of Anemia in Patients with Chronic Renal Failure (CRF) not on Dialysis and not on Erythropoiesis Stimulating Agent (ESA) Treatment
    A.3.2Name or abbreviated title of the trial where available
    PEARL 2
    A.4.1Sponsor's protocol code numberAFX01-13
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAffymax 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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.3.2Product code Inyección de AF37702
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    Parenteral use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAF37702 injection
    D.3.9.1CAS number 913976-27-9
    D.3.9.2Current sponsor codeAF37702
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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.2.1.1.1Trade name Aranesp
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameDarbepoetina alfa
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    Parenteral use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDarbepoetina alfa
    D.3.9.1CAS number 11096-26-7
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100mcg/0.5ml
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Anemia en pacientes con insuficiencia renal crónica (IRC), no dializados y no tratados con agentes estimuladores de la eritropoyesis (AEE)

    Anaemia in Patients with Chronic Renal Failure (CRF) not on Dialysis and not on Erythropoiesis Stimulating Agent (ESA) Treatment
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10058116
    E.1.2Term Nephrogenic anaemia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •Demostrar la seguridad y la eficacia de la inyección de AF37702 en la corrección de la anemia en pacientes con IRC, no dializados y no tratados con AEE.

    •Demostrar la no inferioridad de la inyección de AF37702 respecto a darbepoetina alfa en el aumento de la hemoglobina (Hb) en pacientes con IRC, no dializados y no tratados con AEE.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.El paciente ha sido informado de la naturaleza investigacional del estudio y ha otorgado su consentimiento informado por escrito, en cumplimiento de las directrices institucionales, locales y nacionales.
    2.Hombres y mujeres que hayan cumplido los 18 años.
    3.Las mujeres en edad fértil y sexualmente activas deben estar dispuestas a usar un método anticonceptivo altamente eficaz como mínimo durante las 4 semanas previas a la aleatorización, y deben estar dispuestas a continuar usándolo como mínimo hasta que hayan transcurrido 4 semanas a partir de la administración de la última dosis del tratamiento del estudio.
    4.Pacientes con insuficiencia renal crónica con una filtración glomerular estimada < 60 ml/min/1,73 m2, calculada mediante la fórmula de 4 variables proveniente del estudio de modificación de la dieta en la enfermedad renal (Modification of Diet in Renal Disease, MDRD), dentro de las cuatro semanas antes de la aletorización y que no esté previsto que inicien diálisis en 12 semanas como mínimo.
    5.Dos valores consecutivos de Hb ≥ 8,0 g/dl y < 11,0 g/dl en las 4 semanas previas a la aleatorización, con una diferencia ≤ 1,3 g/dl entre los dos valores, que deben haberse medido con menos de 5 días de separación, y con el último valor medido en los 10 días previos a la aleatorización.
    6.Una saturación de transferrina (TSAT) ≥ 20% o un nivel de ferritina ≥ 100 ng/ml en las 4 semanas previas a la aleatorización.
    7.Un nivel de folato en suero o en eritrocitos superior o igual al límite inferior de la normalidad durante las 4 semanas previas a la aleatorización.
    8.Un nivel de vitamina B12 superior o igual al límite inferior de la normalidad durante las 4 semanas previas a la aleatorización.
    E.4Principal exclusion criteria
    1.Mujeres embarazadas o en período de lactancia.
    2.Tratamiento con AEE en las 12 semanas previas a la aleatorización.
    3.Intolerancia demostrada a cualquier AEE, aporte complementario de hierro por vía parenteral, o molécula pegilada.
    4.Tratamiento previo con hemodiálisis crónica o diálisis peritoneal crónica. (Nota: Cumplen con los requisitos los pacientes sometidos a un trasplante de riñón hace por lo menos 6 meses, y que no hayan recibido diálisis crónica post-trasplante).
    5.Trastornos hemorrágicos o de la coagulación demostrados.
    6.Enfermedad hematológica demostrada o causa de la anemia distinta a la enfermedad renal (p. ej.: aplasia eritrocitaria pura (PRCA), anemia drepanocítica homocigótica, talasemia, mieloma múltiple, anemia hemolítica, síndrome mielodisplásico, etc.).
    7.Hipertensión mal controlada en las 4 semanas previas a la aleatorización, según el criterio médico del investigador.
    8.Cualquier enfermedad o afección clínicamente significativa que, a juicio del investigador, pueda interferir en el cumplimiento del protocolo o en la capacidad de un paciente de otorgar su consentimiento informado.
    9.Indicios de cáncer activo durante el año previo a la aleatorización. (Téngase en cuenta que, para el propósito de este protocolo, cáncer activo no incluye los siguientes: cáncer de piel distinto del melanoma u otro carcinoma localizado que se haya extirpado completamente, otros cánceres para los que el tratamiento finalizó al menos un año atrás y no continúan en tratamiento ni presentan indicios de metástasis, y otros cánceres que fueron diagnosticados y cuyo tratamiento finalizó hace más de un año, y que durante el año anterior no han presentado indicios de metástasis y se han tratado únicamente con terapia hormonal adyuvante).
    10.Un trasplante de riñón programado (Nota: no se excluirá a los pacientes que estén actualmente en una lista de espera para recibir un trasplante, a menos que haya un donante identificado).
    11.Cirugía programada que pueda causar una pérdida importante de sangre.
    12.Transfusión de eritrocitos o de sangre completa en las 12 semanas previas a la aleatorización.
    13.Exposición previa a cualquier fármaco en investigación en las 4 semanas anteriores a la aleatorización, o recepción prevista de cualquier fármaco en investigación, distinto al especificado en este protocolo, durante el transcurso del estudio.
    14.Exposición previa a la inyección de AF37702.
    E.5 End points
    E.5.1Primary end point(s)
    Cambio medio del valor de Hb entre el valor inicial (la media de los tres valores más recientes de Hb determinados por el laboratorio central, previos a la Dosis 1 y el del período de evaluación (la media de los valores de Hb de las semanas 25 a 36).
    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 Yes
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned5
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Último paciente, última visita es la finalización del ensayo
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 228
    F.4.2.2In the whole clinical trial 450
    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 Decision2008-03-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-12-31
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 03 16:13:03 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA