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    Summary
    EudraCT Number:2017-001899-32
    Sponsor's Protocol Code Number:RESINFENOL
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-08-02
    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 number2017-001899-32
    A.3Full title of the trial
    Crossover and randomized clinical trial on the effect of Resincolestiramine in the intestinal absorption of new uremic toxins in patients in hemodialysis with chronic renal insufficiency
    Ensayo clínico cruzado y aleatorizado sobre el efecto de Resincolestiramina en la absorción intestinal de nuevas toxinas urémicas en pacientes con insuficiencia renal crónica en hemodiálisis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Crossover and randomized clinical trial on the effect of Resincolestiramine in the intestinal absorption of new uremic toxins in patients in hemodialysis with chronic renal insufficiency
    Ensayo clínico cruzado y aleatorizado sobre el efecto de Resincolestiramina en la absorción intestinal de nuevas toxinas urémicas en pacientes con insuficiencia renal crónica en hemodiálisis.
    A.3.2Name or abbreviated title of the trial where available
    RESINFENOL
    RESINFENOL
    A.4.1Sponsor's protocol code numberRESINFENOL
    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 SponsorDr. Abelardo Aguilera Peralta
    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 supportLaboratorios Rubio
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGina Paola Mejía Abril
    B.5.2Functional name of contact pointCoordinación de ensayos clínicos
    B.5.3 Address:
    B.5.3.1Street AddressCalle Diego de León 62 planta 7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28006
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491 520 25 40
    B.5.6E-mailginapaola.mejia@salud.madrid.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.2.1.1.1Trade name Resincolestiramina
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Rubio, S.A.
    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 Powder for oral suspension
    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 INNCOLESTYRAMINE
    D.3.9.2Current sponsor codeResincolestiramine
    D.3.9.4EV Substance CodeSUB01427MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 insufficiency
    Insuficiencia renal crónica
    E.1.1.1Medical condition in easily understood language
    Chronic renal insufficiency
    Insuficiencia renal crónica
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    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 of the study is to quantify the effect on serum concentrations of phenols and indoles and AGEs, after administration of Resincolestiramine in patients with chronic renal failure in hemodialysis.
    El objetivo principal del estudio es cuantificar el efecto en la concentración sérica de fenoles e índoles y AGEs, tras la administración de Resincolestiramina en pacientes con insuficiencia renal crónica en hemodiálisis.
    E.2.2Secondary objectives of the trial
    •To characterize the profile of blood lipoproteins using the Liposcale test.
    •To evaluate the effect of the treatment on the different parameters obtained by the Liposcale test.
    •To characterize the blood glycoprotein profile using Nuclear Magnetic Resonance.
    •To evaluate the effect of the treatment on the different parameters obtained through the characterization of blood glycoproteins.
    •To Evaluate the degree of association between the variables obtained by NMR and the quantification of AGEs
    •To quantify the variation in serum levels of CML, TNF-γ, IL-6 and Protein C Reactive after treatment
    •To study the safety of treatment
    -Caracterizar el perfil completo de lipoproteínas sanguíneas mediante el test Liposcale.
    -Evaluar el efecto del tratamiento sobre los distintos parámetros obtenidos mediante el test Liposcale.
    -Caracterizar el perfil de glicoproteínas sanguíneas en pacientes con insuficiencia renal crónica en hemodiálisis mediante Resonancia Magnética Nuclear (RMN).
    -Evaluar el efecto del tratamiento con Resincolestiramina sobre los distintos parámetros obtenidos mediante la caracterización de glicoproteínas sanguíneas.
    -Evaluar el grado de asociación entre las variables obtenidas mediante RMN y la cuantificación de AGEs.
    -Cuantificar la variación en los niveles séricos de CML, TNF-, IL-6 y Proteína C Reactiva tras el tratamiento con Resincolestiramina.
    -Estudiar la seguridad del tratamiento con Resincolestiramina en pacientes con insuficiencia renal crónica en hemodiálisis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Patients who give their written consent to participate in the study.
    •Men and women between 18 and 80 years
    •Women of childbearing potential should use an effective contraceptive method (hormonal contraceptives, intrauterine device, condom) or refrain from having sex in order not to get pregnant. A woman is considered to be fertile after menarche and to become postmenopausal, unless she has undergone a permanent sterilization procedure (hysterectomy, salpingectomy, bilateral oophorectomy). A postmenopausal state is defined as absence of menstruation for 12 months without an alternative medical cause
    •Adequate dialysis criteria according to the KDOQI guidelines: Target of spKt / V> 1.4 per hemodialysis session for patients treated three times per week
    •Stable renal disease in the last 3 months. Chronic kidney disease is considered stable when it meets the following criteria:
    -The associated chronic pathologies are adequately controlled and have not required hospitalization in the last 3 months.
    -The patient has no hemodynamic changes (AT ≥ 90/60 and ≤ 160/90 mm Hg) outside the hemodialysis session.
    -There are no signs of acute infection valued by the absence of leukocytosis in the blood count
    -There is no clinical evidence of tumor pathology at the discretion of the investigator
    Pacientes que firmen el consentimiento informado
    Hombres y mujeres entre 18 y 80 años
    Las mujeres en edad fértil deben utilizar un método anticonceptivo eficaz (anticonceptivos hormonales, dispositivo intrauterino, preservativo) o abstenerse de mantener relaciones sexuales con el fin de no quedarse embarazada. Se considera que una mujer es fértil después de la menarquia y hasta convertirse en posmenopáusica, a menos que se haya sometido a un procedimiento de esterilización permanente (histerectomía, salpingectomía, ooforectomía bilateral). Un estado posmenopáusico se define como ausencia de menstruación durante 12 meses sin una causa medica alternativa
    Criterios de diálisis adecuada de acuerdo a las guías KDOQI: Objetivo de spKt/V >1,4 por sesión de hemodiálisis para los pacientes tratados tres veces por semana
    Enfermedad renal estable en los últimos 3 meses. Se considera que la enfermedad renal crónica está estable cuando cumple los siguientes criterios:
    oLas patologías crónicas asociadas están controladas adecuadamente y no hayan requerido hospitalización en los últimos 3 meses.
    oEl paciente no presenta alteraciones hemodinámicas (TA ≥ 90/60 y ≤ 160/90 mm Hg) fuera de la sesión de hemodiálisis.
    oNo hay signos de infección aguda valorable por la ausencia de leucocitosis en el hemograma
    oNo existe evidencia clínica de patología tumoral a criterio del investigador
    E.4Principal exclusion criteria
    •Pregnant or lactating women.
    •Total cholesterol values lower than 150 mg/dL with or without lipid-lowering treatment.
    •Hemoglobin value ≤10 mg / dL (according to KDOQI guidelines).
    •Serum PTH levels ≥750 pg / mL (moderate hyperparathyroidism).
    •Prothrombin activity below 80% and / or treatment with acenocoumarol or warfarin
    •Patients receiving Resincolestiramine on medical advice.
    •Antecedents of autoimmune diseases and / or treatment with immunosuppressants
    •Hypersensitivity to the active substance or to any of the excipients (carboxymethylcellulose, propylene glycol alginate, colloidal silica, sodium saccharin, sodium cyclamate, strawberry flavor)
    •History of peptic ulcer
    •Complete biliary obstruction
    Mujeres embarazadas o en periodo de lactancia.
    Valores de colesterol total inferiores a 150 mg/dL con o sin tratamiento hipolipemiante.
    Valor de hemoglobina ≤10 mg/dL (según las guías KDOQI).
    Niveles séricos de PTH ≥750 pg/mL (hiperpartiroidismo moderado).
    Actividad de protrombina por debajo del 80% y/o tratamiento con acenocumarol o warfarina
    Pacientes que estén recibiendo tratamiento con Resincolestiramina por indicación médica.
    Antecedentes de enfermedades autoinmunes y/o tratamiento con inmunosupresores
    Hipersensibilidad al principio activo o a alguno de los excipientes (carboximetilcelulosa, alginato de propilenglicol, sílice coloidal, sacarina sódica, ciclamato sódico, aroma de fresa)
    Historia de ulcera péptica
    Obstrucción biliar completa
    E.5 End points
    E.5.1Primary end point(s)
    Percentage reduction in the serum concentration of phenols and indols and AGEs after treatment with Resincolestiramine during 3 months with respect to the 3-month period without treatment.
    Porcentaje de reducción de la concentración sérica de fenoles e indoles y AGEs tras el tratamiento con Resincolestiramina durante 3 meses con respecto al periodo de 3 meses sin tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 meses
    E.5.2Secondary end point(s)
    Complete profile of blood lipoproteins using the Liposcale test. The test allows to determine the size and concentration of particles and lipids of the main lipoprotein fractions (VLDL, LDL and HDL) as well as the particle concentration of a total of nine lipoprotein subfractions:
    -The lipid combination: Cholesterol and Triglycerides of each fraction (VLDL-C, VLDL-TG, IDL-C, LDL-TG, HDL-C and HDL-TG)
    - Average size of particles of each main fraction (VLDL-Z, LDL-Z and HDL-Z).
    (Total, large VLDL-P, medium VLDL-P, small VLDL-P), LDL (total, large LDL-P, LDL-P median, LDL-P) and HDL Medium, small HDL-P).
    Profiling of blood glycoproteins by Nuclear Magnetic Resonance (NMR).
     Serum levels of TNF-γ, IL-6 and Protein C Reactive.
    Number of adverse events in patients with chronic renal failure on hemodialysis under treatment with Resincolestiramine
    Perfil completo de lipoproteínas sanguíneas mediante el test Liposcale. El test permite determinar el tamaño y la concentración de partículas y de lípidos de las principales fracciones de lipoproteínas (VLDL, LDL y HDL) así como la concentración de partículas de un total de nueve subfracciones lipoproteicas:
    -Composición lipídica: Colesterol y Triglicéridos de cada fracción (VLDL-C, VLDL-TG; IDL-C, IDL-TG; LDL-C, LDL-TG; HDL-C y HDL-TG)
    -Tamaño medio de partículas de cada fracción principal (VLDL-Z, LDL-Z y HDL-Z).
    -Número de partículas de las fracciones principales de lipoproteínas y sus subclases VLDL (total, Large VLDL-P, Medium VLDL-P, Small VLDL-P), LDL (total, Large LDL-P, Medium LDL-P, Small LDL-P) y HDL (total, Large HDL-P, Medium HDL-P, Small HDL-P).
    Perfil de glicoproteínas sanguíneas mediante Resonancia Magnética Nuclear (RMN).
    Niveles séricos de TNF-, IL-6 y Proteína C Reactiva.
    Número de acontecimientos adversos en pacientes con insuficiencia renal crónica en hemodiálisis en tratamiento con Resincolestiramina.
    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 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) 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 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 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 concerned3
    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
    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
    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: 38
    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 state58
    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 Decision2017-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-12-28
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