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    Summary
    EudraCT Number:2020-000484-23
    Sponsor's Protocol Code Number:NEFRTX1
    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:2024-09-09
    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 number2020-000484-23
    A.3Full title of the trial
    CHARACTERIZATION OF RITUXIMAB PHARMACOKINETICS IN PATIENTS WITH KIDNEY DISEASES WITH PRIMARY GLOMERULAR AFFECTATION
    CARACTERIZACIÓN DE LA FARMACOCINÉTICA DE RITUXIMAB EN PACIENTES CON ENFERMEDADES RENALES CON AFECTACIÓN GLOMERULAR PRIMARIA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the particular characteristics of patients with kidney diseases that could affect the behavior of rituximab in their organism.
    Investigación de las variables de pacientes con enfermedades del riñón que podrían afectar al comportamiento de rituximab en su organismo.
    A.4.1Sponsor's protocol code numberNEFRTX1
    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 SponsorVall d'Hebron Institute of Research
    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 supportNone
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVall d'Hebron Institute of Research
    B.5.2Functional name of contact pointMaria Larrosa Garcia
    B.5.3 Address:
    B.5.3.1Street AddressPasseig de la Vall d'Hebron, 119-129
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number0034934 89 30 00
    B.5.6E-mailmlarrosa@vhebron.net
    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 Rixathon
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameRITUXIMAB
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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
    KIDNEY DISEASES WITH PRIMARY GLOMERULAR AFFECTATION (glomerulonefritis membranosa, glomerulonefritis por cambios mínimos, vasculitis, glomerulosclerosis focal y segmentaria.)
    ENFERMEDADES RENALES CON AFECTACIÓN GLOMERULAR PRIMARIA
    (glomerulonefritis membranosa, glomerulonefritis por cambios mínimos, vasculitis, glomerulosclerosis focal y segmentaria.)
    E.1.1.1Medical condition in easily understood language
    Diseases affecting the kidney affceting the glomeruli related with altered immune response.
    Enfermedades renales que afectan a los glomerulos y están relacionadas con alteraciones del sistema inmune.
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    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 objetive of this study is to characterize the rituximab pharmacokinetic profile in patients with kidney disease with primary glomerular involvement; as well as evaluating the influence of proteinuria, FCGRT polymorphism and the presence of anti-drug antibodies on rituximab clearance.
    El objetivo principal de este ensayo clínico es caracterizar el perfil farmacocinético de rituximab en pacientes con enfermedad renal con afectación glomerular primaria y evaluar la influencia sobre el mismo de la proteinuria, el polimorfismo del receptor neonatal de Fc (FCGRT) y la presencia o no de anticuerpos frente al fármaco.
    E.2.2Secondary objectives of the trial
    - To evaluate the impact of rituximab serum concentration on efficacy and safety one year after treatment (complete remission, partial remission, no remission, time to remission, relapse, tolerability, toxicity and adverse events)
    - In case parameters affecting rituximab pharmacokinetics are identified (such as proteinuria, FCGRT polymorphism and anti-drug antibodies), we aim to measure ther impact.
    Evaluar la influencia de la concentración de RTX en sangre y los resultados en
    cuanto a eficacia clínica y seguridad del tratamiento tras el año de seguimiento
    (remisión, remisión parcial, o no remisión de la enfermedad; tiempo de remisión;
    recidiva de la enfermedad tras remisión; tolerancia, toxicidad y aparición de
    acontecimientos adversos). • En caso de objetivarse un perfil farmacocinético de
    RTX, cuantificar específicamente el efecto sobre los parámetros farmacocinéticos
    de RTX de los parámetros analizados (proteinuria, polimorfismo FCGRT y
    anticuerpos anti-RTX).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients disgnosed with kidney disease with primary glomerular affectation (membranous glomerulonephritis, minimal-change glomerulonephritis, vasculitis, Focal segmental glomerulonephritis)
    - Patients whose best treatment option is rituximab, according to current international clinical guidelines.
    - Patients whose treatment has been approved by the Committee for Evaluation of Treatment Special Use in our Hospital.
    - Older than 18 years old
    - Who have not received rituximab in the last 6 months.
    - Who can commit for a year follow up in our hospital.
    - Pacientes con diagnóstico de enfermedad renal con afectación glomerular
    (glomerulonefritis membranosa, glomerulonefritis de cambios mínimos, vasculitis, glomerulosclerosis focal y segmentaria).
    - Pacientes para los que el tratamiento con RTX sea la mejor opción terapéutica de acuerdo con las guías de práctica clínica internacionales actuales. - Pacientes cuyo tratamiento con RTX sea aprobado porla Comissió d’Avaluació de Tractaments en Condicions Especials d’Ús (CATSEU).
    - Mayores de 18 años.
    - Pacientes con capacidad de comprender y firmar el
    consentimiento informado. - Que no hayan recibido RTX en los últimos 6 meses. - Que puedan comprometerse a realizar un seguimiento a un año en nuestro centro.
    E.4Principal exclusion criteria
    - Participation in any other clinical trial.
    - Limitations in understanding the Informed Consent.
    - Being unable to commit for 1 year follow up.
    - Live expectancy < 6 months.
    - Contraindication for rituximab treatment.
    - Participar en otro ensayo clínico actualmente o en los últimos 6 meses. -
    Presentar limitaciones para comprender correctamente el consentimiento
    informado.
    - Incapacidad de compromiso para realizar el seguimiento por parte de
    Nefrología del HUVH durante un año.
    - Presencia de alguna contraindicación para
    el tratamiento con RTX (antecedentes de reacción alérgica, infección VHB
    activa…).
    - Presentar una expectativa vital inferior a 6 meses.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoints are those related with rituximab pharmacokinetics: serum rituximab concentration (mcg/L), half live (h), distribution volume (ml/kg), serum clearance, Area under the curve (mch*h/L).
    La variable de evaluación del objetivo principal es, por un lado, el valor de
    concentración de RTX en sangre (suero, μg/L) a distintos tiempos. Y expresada en forma de parámetros farmacocinéticos, tras el análisis correspondiente: semivida de eliminación, horas [t1/2], volumen de distribución, mL/kg [Vd], aclaramiento plasmático, mL/h/kg [Cl], área bajo curva concentración-tiempo, μg*h/L [AUC]). Y por otro, el valor de proteinuria (gramos de proteína por gramo de creatinina en sangre, gramos de proteína en orina de 24 horas), anticuerpos anti-RTX (positivo/negativo) y polimorfismo FCGRT.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1, 7, 15, 28 and 45.
    Días 1, 7, 28 y día 45
    E.5.2Secondary end point(s)
    Efficacy will be evaluated using proteinuria(grams of protein in urine collected during 24 hours and ratio between grams of protein:grams of creatinine in urine), albumin serum concentration, ANCA, AntiPLA2R, glomerular filtration, reactive C protein, limphocytes count.
    Para valorar la eficacia del tratamiento se tendrán en cuenta los valores de
    albúmina y creatinina en sangre, aclaramiento renal de creatinina, proteinuria
    (gramos de proteína por gramo de creatinina en sangre, gramos de proteína en
    orina de 24 horas), anticuerpos anticitoplasma de neutrófilos (ANCA) en pacientes
    con glomerulonefritis y anti-PLA2R en pacientes con glomerulonefritis membranosa.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 28, 45, 180 and 365.
    Días 28, 45, 180 y 365
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 No
    E.8.1.1Randomised No
    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 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 No
    E.8.2.3Other No
    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 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
    LVLS
    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 months
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state35
    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 inclusion in the trial does not impact the clinical management of the patient. After completing the trial, patients witl lhave the regular medical care.
    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 Decision2020-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-06
    P. End of Trial
    P.End of Trial StatusOngoing
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