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    Summary
    EudraCT Number:2011-001929-24
    Sponsor's Protocol Code Number:1392-H-199
    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:2011-08-09
    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 number2011-001929-24
    A.3Full title of the trial
    Randomised, open-label, crossover clinical trial to evaluate the antiproteinuric effect of three different types of diuretics (hydrochlorothiazide, amiloride and spironolactone) in patients with chronic proteinuric nephropathies.
    Ensayo clínico aleatorizado, abierto, cruzado que compara el efecto antiproteinúrico de tres tipos de diuréticos (hidroclorotiazida, amilorida y espironolactona) en pacientes con nefropatías crónicas proteinúricas.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Antiproteinuric effect of three different types of diuretics in patients with chronic proteinuric nephrophaties.
    Efecto antiproteinúrico de tres tipos diferentes de diuréticos en pacientes con nefropatías crónicas proteinúricas.
    A.4.1Sponsor's protocol code number1392-H-199
    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 SponsorFundación para la Investigación Biomédica del Hospital 12 de Octubre
    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 supportMinisterio de Sanidad y Política Social
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario 12 Octubre
    B.5.2Functional name of contact pointServicio de Nefrología
    B.5.3 Address:
    B.5.3.1Street AddressAvda de Andalucía, s/n
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28041
    B.5.3.4CountrySpain
    B.5.4Telephone number34913908284
    B.5.5Fax number34913908207
    B.5.6E-mailemoralesr@senefro.org
    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.2.1.2Country 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.3.1Product nameHidroclorotiazida
    D.3.4Pharmaceutical form Tablet
    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 INNHidroclorotiazida
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.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 Yes
    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.3.1Product nameEspironolactona
    D.3.4Pharmaceutical form Tablet
    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 INNEspironolactona
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.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 Yes
    D.2.1.1.1Trade name Ameride 5/50 mg comprimidos
    D.2.1.1.2Name of the Marketing Authorisation holderRovi Imaging, S.L.
    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.3.1Product nameAmeride
    D.3.4Pharmaceutical form Tablet
    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 INNHidroclorotiazida
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAmilorida
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Chronic proteinuric nephropathies
    Nefropatías crónicas proteinúricas
    E.1.1.1Medical condition in easily understood language
    Chronic kidney disease with proteins in urine
    Enfermedad renal crónica con presencia de proteínas en orina
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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
    The main objective is to compare the percentage reduction of albuminuria/proteinuria in patients with proteinuric chronic kidney disease of any etiology treated with hydrochlorothiazide vs amiloride+hydrochlorothiazide vs spironolactone.
    Comparar el porcentaje de reducción de la albuminuria/proteinuria en los pacientes con nefropatías crónicas proteinúricas de cualquier etiología tratados con hidroclorotiazida vs hidroclorotiazida+amilorida vs espironolactona.
    E.2.2Secondary objectives of the trial
    To evaluate the percentage of proteinuric patients reduces by 30 and 50% in each group of diuretic therapy. Knowing renal function (creatinine clearance and MDRD-4) at the beginning and end of each group of diuretic therapy. Determine changes in blood pressure in each treatment group. Determine changes in plasma electrolytes (sodium, potassium) with different types of diuretics. To determine the changes in urinary electrolytes (sodium, potassium) in each group of diuretic therapy. Determine changes in plasma renin and aldosterone with different types of diuretics. To evaluate the safety and tolerability of different treatment regimens.
    Determinar el porcentaje de pacientes que reducen la proteinuria en un 30 y un 50% en cada grupo de tratamiento diurético. Conocer la función renal (aclaramiento de creatinina y MDRD-4) al inicio y al final de cada grupo de tratamiento diurético. Determinar los cambios en la presión arterial en cada grupo de tratamiento. Determinar los cambios en los electrolitos plasmáticos (sodio, potasio) con los distintos tipos de diuréticos. Determinar los cambios en los electrolitos urinarios (sodio, potasio) en cada grupo de tratamiento diurético. Determinar los cambios en los valores plasmáticos de la renina y aldosterona con los diferentes tipos de diuréticos. Evaluar la seguridad y tolerabilidad de las diferentes pautas de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients over 18 years and younger than 80 years.
    Patients with diabetes or chronic kidney disease with albuminuria among nondiabetic 300-3000 mg/24 h.
    Patients with stable kidney function during the last 3 months: serum creatinine <2.0 mg/dL or GFR> 60 mL/min/1.73 m2 (Grades 1 and 2 as K-DOQI guidelines included in Annex B of the Protocol).
    Patients who are receiving ACE inhibitors as a treatment prior antiproteinuric, ARA II or a combination of both.
    Patients who are able to understand the purpose and risks of the trial, which has been fully informed and have finally given written informed consent according to ICH-GCP. Patients who can not read and write but adequately understand verbal information provided by the investigator (or designee) verbal informed consent is granted against an independent witness signed the informed consent document.
    Pacientes mayores de 18 años y menores de 80 años.
    Pacientes con nefropatías crónicas diabéticas o no diabéticas con albuminuria entre 300-3000 mg/24 h.
    Pacientes con función renal estable durante los últimos 3 meses: creatinina sérica <2.0 mg/dL o filtrado glomerular >60 ml/min/1.73 m2 (Grados 1 y 2 según las guías K-DOQI incluidas en el anexo b del protocolo).
    Pacientes que estén recibiendo como tratamiento antiproteinúrico previo IECA, ARA II o la combinación de ambos.
    Pacientes que sean capaces de enterder el objetivo, los riesgos del ensayo, que haya sido completamente informados y finalmente hayan otorgado el consentimiento informado por escrito de acuerdo con la ICH-BPC. Los pacientes que no puedan leer y escribir pero que entiendan adecuadamente la información verbal proporcionada por el investigador (o personal designado) otorgarán el CI verbal frente a testigo independiente que firmará el CI.
    E.4Principal exclusion criteria
    Patients allergic or intolerant to hydrochlorothiazide, spironolactone or amiloride.
    Patients who are or have been involved in another clinical trial and / or are taking or have taken an experimental drug not registered in the last 28 days.
    Patients with poorly controlled blood pressure (SBP> 160 mm Hg or DBP> 100 mm Hg).
    Patients with a history of cardiovascular events (stroke, ischemic heart disease) in the last 6 months.
    Patients treated with steroids, NSAIDs or other immunosuppressants.
    Patients with a history of renovascular disease, obstructive uropathy, autoimmune diseases, cancer, drug abuse.
    Patients who are pregnant or breastfeeding.
    Pacients who do not sign informed consent.
    Low likelihood of compliance with scheduled visits in the protocol.
    Pacientes alérgicos o con intolerancia a hidroclorotiazida, espironolactona o amilorida.
    Pacientes que estén participando o hayan participado en otro EC y/o estén tomando o hayan tomado algún fármaco experimental no registrado en los últimos 28 días.
    Pacientes con mal control de la Presión Arterial (PAS >160 mm Hg o PAD >100 mm Hg).
    Pacientes con historia de eventos cardiovasculares (accidente cerebrovascular, cardiopatía isquémica) en los últimos 6 meses.
    Pacientes en tratamiento con esteroides, antiinflamatorios no esteroideos u otros inmunosupresores.
    Pacientes con historia de enfermedad renovascular, uropatía obstructiva, enfermedades autoinmunes, cáncer, consumo de drogas.
    Pacientes embarazadas o en periodo de lactancia.
    Pacients que no firmen el consentimiento informado.
    Poca probabilidad de cumplimiento de las visitas programadas en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy parameter is to compare the percentage reduction of albuminuria / proteinuria in patients with proteinuric renal disease of any etiology treated with hydrochlorothiazide versus hydrochlorothiazide + amiloride versus spironolactone.
    El parámetro principal de eficacia consiste en comparar el porcentaje de reducción de la albuminuria/proteinuria en los pacientes con nefropatías proteinúricas de cualquier etiología tratados con hidroclorotiazida versus hidroclorotiazida + amilorida versus espironolactona.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary end point will be evaluated for each treatment, at baseline and at the end of each treatment.
    La variable principal se evaluará con cada tratamiento, a nivel basal y al finalizar cada tratamiento.
    E.5.2Secondary end point(s)
    1. Percentage of patients with a reduction in proteinuria over 25%.
    2. Determination of renal function assessed by serum creatinine and GFR determined by MDRD-4 after each treatment period.
    3. Changes in weight and BMI after each treatment period.
    4. Changes in SBP and DBP after each treatment period.
    5. Percentage of patients with hyperkalemia (K> 5.5 mEq / L) during the treatment period.
    6. Changes in plasma renin and aldosterone after each treatment period.
    7. Changes in uric acid levels after each treatment period.
    8. Changes in urinary sodium values ​​after each treatment period.
    9. Percentage of patients who abandon treatment.
    10. Percentage of patients with adverse effects in each treatment group.
    1. Porcentaje de pacientes con una reducción de la proteinuria superior al 25%.
    2. Determinación de la función renal evaluada por creatinina sérica y FGR determinado por MDRD-4 después de cada período de tratamiento.
    3. Cambios en el peso y el IMC después de cada período de tratamiento.
    4. Cambios en la PAS y la PAD después de cada período de tratamiento.
    5. Porcentaje de pacientes con hiperpotasemia (K>5.5 mEq/L) durante el período de tratamiento.
    6. Cambios en los valores plasmáticos de renina y aldosterona después de cada período de tratamiento.
    7. Cambios en los valores de ácido úrico después de cada período de tratamiento.
    8. Cambios en los valores de sodio urinario después de cada período de tratamiento.
    9. Porcentaje de pacientes que abandonan el tratamiento.
    10. Porcentaje de pacientes que presentan efectos adversos en cada grupo de tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All of them will be evaluated for each treatment, at baseline and at the end of each treatment.
    Todas se evaluarán para cada tratamiento a nivel basal y tras recibir cada uno de los tratamientos
    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 No
    E.8.1.6Cross over Yes
    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.8.2.4Number of treatment arms in the trial3
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    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 years1
    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 years0
    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.1.1.1In 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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state45
    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 subjects will continue their usual treatment.
    Los sujetos continuarán con su tratamiento 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 Decision2011-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-01
    P. End of Trial
    P.End of Trial StatusOngoing
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