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    Summary
    EudraCT Number:2013-003855-38
    Sponsor's Protocol Code Number:PIERAID-2013
    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:2014-02-27
    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 number2013-003855-38
    A.3Full title of the trial
    Benefits of paricalcitol (Selective vitamin D receptor activator indicated for the prevention and treatment of secondary hyperparathyroidism) on anaemia of inflammation in dialysis patients receiving erythropoiesis-stimulating agents.
    Beneficios de paricalcitol (activador selectivo del receptor de Vitamina D) indicado para la prevención y el tratamiento del hiperparatiroidismo secundario) sobre la anemia de características inflamatorias en los pacientes en diálisis que reciben agentes estimuladores de eritropoyesis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Paricalcitol improves anemia of inflammation
    Paricalcitol mejora la anemia inflamatoria
    A.3.2Name or abbreviated title of the trial where available
    PIERIAD STUDY
    ESTUDIO PIERAID
    A.4.1Sponsor's protocol code numberPIERAID-2013
    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 SponsorMiguel Giovanni Uriol Rivera
    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 supportSon Espases University Hospital
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMiguel Giovanni Uriol Rivera
    B.5.2Functional name of contact pointSon Espases University Hospital
    B.5.3 Address:
    B.5.3.1Street AddressCarretera Valldemosa 79.
    B.5.3.2Town/ cityPalma de Mallorca
    B.5.3.3Post code07120
    B.5.3.4CountrySpain
    B.5.4Telephone number34871871205000
    B.5.5Fax number34871871909733
    B.5.6E-mailmiguelg.uriol@ssib.es
    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 Zemplar
    D.2.1.1.2Name of the Marketing Authorisation holderAbbvie Farmaceutica S.L.U.
    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 Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPARICALCITOL
    D.3.9.1CAS number 131918-61-1
    D.3.9.3Other descriptive namePARICALCITOL
    D.3.9.4EV Substance CodeSUB09627MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number6 to 12
    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 Yes
    D.3.11.13.1Other medicinal product typeVitamin D analog
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Anaemia of inflammation in patients with chronic kidney disease on haemodialysis
    Anemia inflamatoria en pacientes con enfermedad renal crónica en hemodiálisis.
    E.1.1.1Medical condition in easily understood language
    Anaemia of inflammation in patients with chronic kidney disease on haemodialysis
    Anemia inflamatoria en pacientes con enfermedad renal crónica en hemodiálisis.
    E.1.1.2Therapeutic area Body processes [G] - Biological Phenomena [G16]
    MedDRA Classification
    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 percentage change in ESA (epoetin beta) after administration of paricalcitol in patients with anemia of inflammation in hemodialysis patients, mantained Hb plasma levels stabilized.
    Evaluar el cambio porcentual de AEE (beta ?epoetina) tras la administración de paricalcitol en pacientes con anemia de características inflamatorias en pacientes en tratamiento sustitutivo renal mediante hemodiálisis, manteniendo estables los niveles de Hb plasmática.
    E.2.2Secondary objectives of the trial
    To determine the correlation between the change in the requirements of ESA, ferrokinetics, levels of interleukin-6, hepcidin, soluble Klotho, erythropoietin and its influence on the blood pressure 
    Para determinar la correlación entre el cambio en los requisitos de la ESA, ferrocinética, los niveles de interleucina-6, hepcidina, Klotho soluble, eritropoyetina y su influencia en la presion arterial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age ? 18 years.
    -Patients with CKD on haemodialysis of any etiology..
    -Hb between 10 and 12g/dl at least 12 weeks before enrollment in the study.
    -Patients with Hb plasma levels stabilized: Hb variation <or = 1 g / dl for the two months prior to inclusion in the study.
    -Patients with anemia of renal etiology.
    -ESA treatment with stable doses for 2 months prior to baseline.Stable dose ESA Definition: Variation <or = 3000UI/week.
    -Iron status for a good erythropoietic response (ferritin> 200 ng / mL and transferrin saturation index (IST):> = 30%).
    -KT / V ? 1.2 ( Dauguirdas-2nd generation).
    -Calcium concentrations between : 8.4 to 9.5 mg / dl and phosphorus: 3.5-5.5 mg / dl.
    -Vitamin D 25OH normal ? 15 ng / ml (patients with lower levels will be supplemented with calcifediol 16000 IU / bi-weekly for 6 weeks in selected patients).
    -PTHi concentrations> = 150 pg / mL and <or = to 300 pg / ml.
    -Patients who accept their inclusion in the study and sign informed consent.
    -Edad ? 18 años.
    -Pacientes con ERC de cualquier etiología estadio 5.
    -Concentración de Hb entre 10 y 12g/dl al menos durante las 12 semanas previas a la inclusión en el estudio.
    -Pacientes con niveles estables de Hb plasmática: variación de Hb < o = a 1 g/dl respecto a los dos meses previos a la inclusión en el estudio.
    -Pacientes con anemia de etiología renal en tratamiento con AEE con dosis estables en los 2 meses previos al inicio del estudio.Definición dosis estable AEE: Variación < ó = a 3000UI/semana.
    -Ferrocinética adecuada para buena respuesta eritropoyética (ferritina:> 200 ng/ml e índice de saturación de trasferrina (IST): >= 30%).
    -KT/V ? 1.2 (según técnica de Dauguirdas-2ª generación).
    -Pacientes con concentraciones de calcio: 8,4-9,5 mg/dl y fósforo: 3,5-5,5 mg/dl.
    -Pacientes con concentraciones circulantes de 25OH vitamina D normales ? 15 ng/ml (aquellos pacientes con niveles de 25(OH) vitamina D inferior a al objetivo establecido serán suplementados previamente a la visita basal con calcifediol 16000 UI/bisemanal durante 6 semanas).
    -Pacientes con concentraciones circulantes de PTH >= 150 pg/mL y < o = a 300 pg/ml.
    -Pacientes que acepten su inclusión en el estudio y firmen consentimiento informado.
    E.4Principal exclusion criteria
    -Epoetin beta dose > 18,000 IU / weekly.
    - Pregnant woman of childbearing age or gestational wishes or not to use adequate contraception.Contraceptive method is considered unsuitable: the Ogino-Knaus.
    - Active bleeding episode or history of transfusion the 2 months prior to baseline.
    - Patients with non-renal causes of anemia:malignancies, folic acid or vitamin B12 deficiency,hemoglobinopathies, hemolysis, pure red cell aplasia secondary to erythropoietin.
    - Patients treated with synthetic analogs of 1,25-OH2-vitamin D or selective modulators of calcium-sensing receptor in the 3 months prior to inclusion in the study.
    - Acute or chronic symptomatic: heart failure (IV-NYHA), infection or inflammatory disease, uncontrolled hypertension that requires the suspension of epoetin beta, thrombocytopathies, aplastic anemia.
    - Immunosuppressive treatment with uncontrolled Hb level
    - Allergy to paricalcitol or any of its components.
    -Precisar en el momento de la inclusión en el estudio dosis de beta-epoetina superiores a 18000 UI/semana.
    -Mujer embarazada o en edad fértil con deseos gestacionales o que no utilice un método anticonceptivo adecuado.Se considera método anticonceptivo no adecuado: el Ogino-Knaus.
    -Episodio de sangrado activo o antecedente de transfusión los 2 meses previos al inicio del estudio.
    -Pacientes con causas no renales de anemia: Neoplasias,Déficit de ácido fólico o vitamina B12, Hemoglobinopatías, Hemólisis, Aplasia pura de serie roja secundaria a eritropoyetina.
    -Pacientes en tratamiento con análogos sintéticos de 1,25-OH2-vitamina D o moduladores selectivos del receptor sensible a calcio en los 3 meses previos a su inclusión en el estudio.
    -Enfermedad aguda o crónica sintomática que contraindique su inclusión en el estudio:Insuficiencia cardiaca grado IV (NYHA), Infección aguda o crónica o enfermedad inflamatoria sintomática o no controlada, Hipertensión arterial (HTA) pobremente controlada que precise la suspensión de la beta-epoetina, Trombocitopatías,Aplasia medular.
    -Tratamiento concomitante inmunosupresor con Hb no controlada.
    -Alergia al paricalcitol o a alguno de sus componentes.
    E.5 End points
    E.5.1Primary end point(s)
    To assess the percentage change in ESA (epoetin beta) doses required 6 months after administration of paricalcitol versus a placebo group. Percentage change in ESA dose: [(initial ESA dose - dose of ESA in 26th week) / initial ESA dose] x 100.
    Variables evaluated:
    1. Hematology:RBC:Hb, RDW, MCV,Haematocrit, HCM, Reticulocyte index,WBC,Neutrophils (%),Lymphocytes (%),Platelets
    2 Inflammation markers:ESR,fibrinogen:,RCP,Uric acid.
    3 lipid profile:Total cholesterol,HDL-cholesterol,LDL cholesterol,Triglycerides.
    4. Nutritional profile:Albumin,Pre-Albumin, Folic acid,Vitamin B12.
    5. Iron Status:Fe,Ferritin,transferrin,Index transferrin saturation.
    6. Calcium-Phosphorus 6.Metabolismo:Ca,P, Vit D (25 OH), Vit D 1-25 (OH) 2, iPTH,Mg.
    Evaluar el cambio de dosis de AEE(beta-epoetina) tras 6 meses de tratamiento con paricalcitol versus un grupo placebo.o Cambio porcentual en dosis de AEE: [(Dosis de AEE inicial ? Dosis de AEE en 26 semana) / Dosis de AEE inicial] x 100.
    Variables evaluadas:1. Hematología:Recuento eritrocitario, Hb,RDW,VCM, Hto, Índice reticulocitario, recuento Leucocitario,Neutrófilos (%),Linfocitos(%),Plaquetas.
    2. Marcadores de inflamación:VSG,Fibrinógeno, PCR, Ácido úrico:
    3. Lipidograma:Colesterol total, HDL-colesterol, LDL colesterol,Triglicéridos.
    4. Perfil nutricional:Albúmina,Pre-albúmina, Ácido fólico,Vitamina B12.
    5. Ferrocinética:Fe,Ferritina,Transferrina,Indice de saturación de la transferrina:
    6. Metabolismo Calcio-Fósforo:Ca,P,Vit D (25 OH), Vit D 1-25(OH)2, PTHi, Mg.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 meses
    E.5.2Secondary end point(s)
    To determine the correlation between the change in ESA doses and the resulting changes in ferrokinetics, levels of interleukin-6, hepcidin, soluble Klotho and plasma erythropoietin
    To determine the correlation between the change of ESA doses and the resulting changes in blood pressure levels after 24-hour ambulatory monitoring.
    Determinar la correlación entre la variación de los requerimientos de AEE, ferrocinética, niveles de interleuquina-6, hepcidina, Klotho soluble y eritropoyetina plsmáticas
    Determinar la correlación entre la variación de los requerimientos de AEE y los cambios obtenidos en las cifras de tensión arterial tras monitorización ambulatoria durante 24 horas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months
    6 meses
    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 No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 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
    The end of the trial will be 6 months after inclusion of the last patients
    El final del ensayo será 6 meses después de la inclusión de los últimos pacientes
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    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: 46
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    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 state46
    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)
    Patients will be receive treatment as usual, keeping paricalcitol treatment if iPTH levels so require. Those patiens with placebo receive standard treatment.
    Los pacientes recibirán su tratamiento habitual, mantendrán el tratamiento con paricalcitol según niveles de PTHi y práctica clínica habitual. Aquellos pacientes del grupo placebo recibirán tratamiento habitual.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-03
    P. End of Trial
    P.End of Trial StatusOngoing
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