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    Summary
    EudraCT Number:2013-003214-41
    Sponsor's Protocol Code Number:NEF-DIU-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:2013-09-16
    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 number2013-003214-41
    A.3Full title of the trial
    Single center randomized clinical study to compare the efficacy of diuretics in patients in hemodialysis with residual renal function
    Estudio unicéntrico, aleatorizado para comparar la eficacia de la administración de diuréticos en pacientes en hemodiálisis (HD) con función renal residual (FRR)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to compare the efficacy of diuretics in patients in hemodialysis with residual diuresis
    Estudio para comparar la eficacia de los diuréticos en pacientes que están en hemodialisis con diuresis residual
    A.4.1Sponsor's protocol code numberNEF-DIU-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 SponsorFundació Parc Taulí
    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 supportFundació Parc Taulí
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació Parc Taulí
    B.5.2Functional name of contact pointOficina de Recerca
    B.5.3 Address:
    B.5.3.1Street AddressParc Taulí nº 1
    B.5.3.2Town/ citySabadell
    B.5.3.3Post code08208
    B.5.3.4CountrySpain
    B.5.6E-mailafarre@tauli.cat
    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.3.4Pharmaceutical 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 INNFUROSEMIDE
    D.3.9.1CAS number 54-31-9
    D.3.9.4EV Substance CodeSUB07849MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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.3.4Pharmaceutical 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 INNHYDROCHLOROTHIAZIDE
    D.3.9.1CAS number 58-93-5
    D.3.9.4EV Substance CodeSUB08062MIG
    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.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 renal disease stage V in hemodialysis
    Enfermedad Renal crónica en estadio V en hemodiálisis
    E.1.1.1Medical condition in easily understood language
    Renal disease in hemodialysis
    Enfermedad renal en hemodialisis
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10051051
    E.1.2Term Renal disease
    E.1.2System Organ Class 100000004857
    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 effect of combined use of furosemide and hydrochlorothiazide on interdialysis weight gain in patients in HD with residual renal function
    Valorar el efecto del uso combinado de furosemida e hidroclorotiazida sobre la ganancia de peso interHD en pacientes en HD con función renal residual
    E.2.2Secondary objectives of the trial
    To assess the effects of combined use of furosemide and hydrochlorothiazide on the following parameters:
    Diuresis
    REduccion of ultrafiltrate in short and long days inter HD
    Dry weight
    Blood pressure in short and long and long days inter HD
    Plasma K concentration in short inter HD days
    Na, K and Cl in urine in short inter HD days
    Hipotension, cramps and gout episodes
    Use of hipotensive drugs
    HCO3 and uric acid plasma concentration in short HD days
    Creatinine and urine clearance
    Use of K supplements in HD

    To assess the safety of the administraion of furosemide and hydroclorotiazide in this patient population
    Valorar el efecto del uso combinado de furosemida e hidroclorotiazida sobre los siguientes parámetros:
    Diuresis
    Disminución del UF en días cortos y días largos interHD
    Peso seco
    Los niveles de PA preHD en días cortos y días largos de HD
    La concentración de potasio en plasma preHD en los días cortos interHD
    Concentración de sodio, potasio y cloro en orina los días cortos interHD
    La prevalencia de hipotensiones, calambres y crisis de gota en esta población de estudio
    Uso de hipotensores
    La concentración de bicarbonato y ácido úrico en sangre tras el día corto
    Aclaramiento de creatinina y urea
    Uso de suplementos de potasio en hemodiálisis

    Valorar la seguridad de la administración de furosemida + hidroclorotiazida en esta población de pacientes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients older than 18 years of age.
    Patients with chronic renal disease in stage V in Hemodialysis.
    Patients that keep a residual renal function (diuresis equal or greater than 200 ml per day.
    Patients who have been in hemodialysis for at least 3 months at the time of inclusion in the study.
    Patients giving informed consent to participate in the study.
    Pacientes mayores de 18 años.
    Pacientes con enfermedad renal crónica en estadio V en hemodiálisis.
    Pacientes que mantengan función renal residual de igual o mayor 200ml al día.
    Pacientes que hayan estado en hemodiálisis como mínimo durante tres meses.
    Pacientes que otorguen su consentimiento informado a participar en el estudio.
    E.4Principal exclusion criteria
    Patients in hemodialysis with plasma K concentrations lower than 4 mEq/L during the inter HD period in short days.
    Patients in HD requiring K suplements in the dialysis.
    Patients with inter HD weight gain in long days lower than 1 kg.
    Patients with history of adverse events or hypersensibility to the study treatments.
    Patients not giving informed consent to participate in the study.
    Pregnant women or nursing mothers.
    Patients with contraindications to the administration of any of the study diuretics or to the concomitant administraion of both drugs, according to the SPCs.
    Patients that the investigator in charge of the medical care considers the participation in the study would be detrimental.
    Pacientes en hemodiálisis con concentración de potasio en plasma menor de 4 mEq/L en el periodo interhemodiálisis de días cortos.
    Pacientes en hemodiálisis que requieran aportes de potasio en el líquido de diálisis.
    Pacientes en hemodiálisis que presenten ganancia de peso interHD de día largo menor de 1 Kg.
    Pacientes en hemodiálisis, que tengan antecedentes de efectos adversos o hipersensibilidad al tratamiento de estudio.
    Pacientes que no otorguen su consentimiento informado a participar en el estudio.
    Mujeres embarazadas o en período de lactancia.
    Pacientes en los que esté contraindicado según la ficha técnicas, la administración de algunos de los dos fármacos en estudio o la administración conjunta de ambos fármacos.
    Pacientes en los que se considere que la participación en el estudio puede suponer un perjuicio clínico, en opinión del médico responsable del cuidado del paciente.
    E.5 End points
    E.5.1Primary end point(s)
    Inter HD weight gain in long days at the end of each period
    Ganancia de peso interHD en el día largo de hemodiálisis al final de cada periodo de tratamiento y semanalmente
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks
    4 semanas
    E.5.2Secondary end point(s)
    Difference between diuresis at baseline and at the end of each study treatment
    Diferencia entre la diuresis al inicio y al final de cada periodo del estudio
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 weeks
    4 semanas
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Sin tratamiento
    No treatment
    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
    Last subject last visit
    Ultimo paciente ultima visita
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state36
    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)
    None
    Ninguno
    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 Decision2013-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-08
    P. End of Trial
    P.End of Trial StatusOngoing
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