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    Summary
    EudraCT Number:2021-005609-28
    Sponsor's Protocol Code Number:RAV-IgA
    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:2022-01-03
    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 number2021-005609-28
    A.3Full title of the trial
    A PILOT PROOF-OF–CONCEPT STUDY TO ASSESS THE EFFICACY AND SAFETY OF A 6 MONTHS RAVULIZUMAB TREATMENT IN PATIENTS WITH FLARES OF CORTICOSTEROID-RESISTANT IDIOPATHIC IgA NEPHROPATHY
    ESTUDIO PILOTO DE PRUEBA DE CONCEPTO PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE UN TRATAMIENTO CON RAVULIZUMAB DE 6 MESES EN PACIENTES CON BROTES DE NEFROPATÍA IDIOPATIA RESISTENTE A LOS CORTICOSTEROIDES
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess whether the drug Ravulizumab works in patients with kidney problems due to IgA immunoglobulin and who do not respond to corticosteroids
    Estudio para evaluar si el medicamento Ravulizumab funciona en pacientes con problemas renales debidos a la inmunoglobulina IgA y que no responden a los corticoides
    A.4.1Sponsor's protocol code numberRAV-IgA
    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. Alfons Segarra Medrano
    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 supportAlexion Spain
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca Biomèdica - IRBLleida
    B.5.2Functional name of contact pointJoan Antoni Schoenenberger
    B.5.3 Address:
    B.5.3.1Street AddressAv. Alcalde Rovira Roure
    B.5.3.2Town/ cityLleida
    B.5.3.3Post code25198
    B.5.3.4CountrySpain
    B.5.4Telephone number+34973003755
    B.5.6E-mailjas.lleida.ics@gencat.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.2.1.1.1Trade name Ultomiris 300 mg/30 ml
    D.2.1.1.2Name of the Marketing Authorisation holderAlexion Europe SAS
    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 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 INNRavulizumab
    D.3.9.1CAS number 1803171-55-2
    D.3.9.3Other descriptive nameALXN1210
    D.3.9.4EV Substance CodeSUB172162
    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 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
    Treatment for IgA nephropathy flares
    Tratamiento para los brotes de nefropatia causada por IgA
    E.1.1.1Medical condition in easily understood language
    Treatment for outbreaks of kidney problems caused by an immune system protein
    Tratamiento para brotes provocados por problemas renales causado por una proteina del sistema inmunitario
    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 primary objective is to determine the quantitative reduction of proteinuria and haematuria 26 weeks after starting treatment with ravulizumab
    El objetivo primario es determinar la reducción cuantitativa de la proteinuria y la hematuria 26 semanas después de iniciar el tratamiento con ravulizumab
    E.2.2Secondary objectives of the trial
    1.- To determine the number (%) of patients achieving complete remission defined by
    UPCR < 0,3 g/g, number of red blood cells < 5 microliter and improvement of serum
    creatinine to achieve baseline levels (only for patients with AKI) 26 weeks after treatment with ravulizumab.
    2. - To measure the evolution of serum creatinine (quantitative) at 26 weeks.
    3. - To measure the evolution of urine C5b-9 levels (quantitative) at 26 weeks.
    4. - To determine the evolution of haematuria and proteinuria 20 weeks after treatment
    withdrawal (at week 46)
    1.- Determinar el número (%) de pacientes que logran una remisión completa definida por
    UPCR < 0,3 g/g, número de hematíes < 5 microlitros y mejora de la creatinina sérica
    creatinina para alcanzar los niveles basales (sólo para los pacientes con IRA) 26 semanas después del tratamiento con ravulizumab.
    2. - Medir la evolución de la creatinina sérica (cuantitativa) a las 26 semanas.
    3. - Medir la evolución de los niveles de C5b-9 en orina (cuantitativo) a las 26 semanas.
    4. - Determinar la evolución de la hematuria y la proteinuria 20 semanas después de la
    (en la semana 46)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Persistent activity despite adequate standard of care treatment
    1a. Patients with preserved renal function: Ratio proteinuria/creatinine >1
    g/g associated to haematuria > 15 cells/microliter after 6 months of
    treatment with corticosteroids according to the recommendations of the
    guidelines.
    1b. Patients with AKI (acute kidney injury): persistence of haematuria and proteinuria and absence of improvement of renal function 4 weeks after the onset of the outbreak and treatment with 3 corticoesteroid pulses of at least 250 mg followed by 1 mg/Kg/day oral prednisone Patients with evidence of extracapillary proliferation could be considered candidates for treatment with ravulizumab after treatment with the standard of care for this condition with 3 pulses of 6- mehtylprednisolone and at least 1 pulse of
    cyclophosphamide.
    2. Evidence of mesangial deposition of C5b-9with or without capillary
    deposits of C3d.
    3. Increased urinary levels of C5b-9. The reference values for urine C5b-9
    excretion have been obtained from a control group of healthy people
    4. Vaccination against meningococcus, haemophilus and pneumococcus
    5. Absence of specific contraindications for ravulizumab treatment.
    6. Written consent.
    1. Actividad persistente a pesar del tratamiento estándar adecuado
    1a. Pacientes con función renal conservada: Relación proteinuria/creatinina >1 g/g asociada a hematuria > 15 células/microlitro tras 6 meses de tratamiento con corticosteroides según las recomendaciones de las
    directrices.
    1b. Pacientes con IRA (lesión renal aguda): persistencia de hematuria y proteinuria y ausencia de mejora de la función renal 4 semanas después del inicio del brote y tratamiento con 3 pulsos de corticoesteroides de al menos de al menos 250 mg seguidos de 1 mg/Kg/día de prednisona oral Pacientes con evidencia de proliferación extracapilar podrían considerarse candidatos a tratamiento con ravulizumab después del tratamiento con el estándar de atención para esta tratamiento estándar para esta enfermedad con 3 pulsos de 6-metilprednisolona y al menos 1 pulso de ciclofosfamida.
    2. Evidencia de depósito mesangial de C5b-9 con o sin depósitos capilares de
    depósitos capilares de C3d.
    3. Aumento de los niveles urinarios de C5b-9. Los valores de referencia para la excreción de C5b-9
    excreción se han obtenido de un grupo de control de personas sanas
    4. Vacunación contra el meningococo, el haemophilus y el neumococo
    5. Ausencia de contraindicaciones específicas para el tratamiento con ravulizumab.
    6. Consentimiento por escrito.
    E.4Principal exclusion criteria
    1. Concomitant significant renal disease other than IgA nephropathy.
    2. Sustained Blood pressure > 140 / 90 mmHg as defined by 2 or more readings during the run in period, as measured in supine position after 10 minutes of rest.
    3. Secondary aetiologies of IgA nephropathy (e.g. inflammatory bowel disease, celiac disease).
    4. Diagnosis of Henoch-Schonlein Purpura (IgA Vasculitis).
    5. Receipt of an organ transplant (including hematologic transplant).
    6. Clinical laboratory test results considered clinically relevant and unacceptable in the opinion of the Investigator.
    7. Malignancy (except for non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate cancer) within the last 5 years.
    8. Patients with systemic bacterial or fungal infections, as demonstrated by a positive culture result, that require systemic treatment with antibiotics or antifungals. Patients receiving empiric or prophylactic antibiotics are not excluded.
    9. Patients who have received any investigational agent within the last 30 days or are in follow-up of another clinical study prior to study enrolment.
    10. Active psychiatric disorder, including, but not limited to schizophrenia, bipolar disorder, or severe depression requiring current pharmacological intervention.
    11. History of meningococcal infection within 12 months before Screening.
    12. Known contraindication to either of the meningococcal vaccines (group ACWY conjugate and group B vaccines) used in this study. Refer to the most recent local product information for each vaccine for the current list of contraindications.
    13. Known medical history or evidence of chronic liver disease or cirrhosis.
    14. Known human immunodeficiency virus (HIV) infection; hepatitis C virus (HCV) infection or hepatitis B virus infection.
    15. Other medical conditions or comorbidities which, in the opinion of the Investigator, would interfere with study compliance or data interpretation.
    16. Patients who consume more than 14 units of alcohol a week (unit 1 glass of wine [125 mL] = 1 measure of spirits = ½ pint of beer).
    17. Pregnancy
    1. Enfermedad renal significativa concomitante distinta de la nefropatía IgA.
    2. Presión arterial sostenida > 140 / 90 mmHg, definida por 2 o más lecturas durante el período de rodaje, medida en posición supina después de 10 minutos de descanso.
    3. Etiologías secundarias de nefropatía IgA (por ejemplo, enfermedad inflamatoria intestinal, enfermedad celíaca).
    4. Diagnóstico de púrpura de Henoch-Schonlein (vasculitis IgA).
    5. Recepción de un trasplante de órganos (incluido el trasplante hematológico).
    6. Resultados de pruebas de laboratorio clínico considerados clínicamente relevantes e inaceptables en
    opinión del Investigador.
    7. Enfermedad maligna (excepto cánceres de piel no melanoma, carcinoma cervical in situ, carcinoma ductal de mama in situ, o cáncer de próstata en estadio 1) en los últimos 5 años.
    8. Pacientes con infecciones bacterianas o fúngicas sistémicas, demostradas por un resultado positivo del cultivo, que requieran tratamiento sistémico con antibióticos o antifúngicos. No se excluyen los pacientes que reciben antibióticos empíricos o profilácticos.
    9. Los pacientes que hayan recibido algún agente en investigación en los últimos 30 días o estén en seguimiento de otro estudio clínico antes de la inscripción en el estudio.
    10. Trastornos psiquiátricos activos, como esquizofrenia, trastorno bipolar o depresión bipolar o depresión grave que requiera una intervención farmacológica en curso.
    11. Antecedentes de infección meningocócica en los 12 meses anteriores al cribado.
    12. Contraindicación conocida a cualquiera de las vacunas meningocócicas (grupo ACWY conjugada y del grupo B) utilizadas en este estudio. Consulte la información local más reciente sobre el información del producto más reciente de cada vacuna para conocer la lista actual de contraindicaciones.
    13. Historia médica conocida o evidencia de enfermedad hepática crónica o cirrosis.
    14. Infección conocida por el virus de la inmunodeficiencia humana (VIH); infección por el virus de la hepatitis C (VHC)
    o infección por el virus de la hepatitis B.
    15. Otras condiciones médicas o comorbilidades que, en opinión del Investigador, pudieran interferir con el cumplimiento del estudio o la interpretación de los datos.
    16. Pacientes que consumen más de 14 unidades de alcohol a la semana (unidad 1 vaso de vino [125 mL] = 1 medida de licor = ½ pinta de cerveza).
    17. Embarazo
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the quantitative reduction of proteinuria and hematuria 26
    weeks after starting treatment with ravulizumab
    El criterio de valoración principal es la reducción cuantitativa de la proteinuria y la hematuria 26 semanas después de iniciar el tratamiento con ravulizumab
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 month after the treatment
    6 meses después del tratamiento
    E.5.2Secondary end point(s)
    6 month after the treatment
    6 meses después del tratamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Renal function (serum creatinine and glomerular filtration estimated by CKD-EPI formula), complete and biochemical hemogram with liver profile, 24h urine profile
    to assess the presence of proteinuria, urinary sediment and fundamental
    electrolytes (every 15 days the first 3 months and then quarterly).
    - Proportion of patients discontinuing treatment with ravulizumab due to adverse
    effects associated with the drug.
    - Función renal (creatinina sérica y filtración glomerular estimada mediante la fórmula CKD-EPI), hemograma completo y bioquímico con perfil hepático, perfil de orina de 24 horas
    para evaluar la presencia de proteinuria, sedimento urinario y electrolitos
    electrolitos fundamentales (cada 15 días los primeros 3 meses y luego trimestralmente).
    - Proporción de pacientes que interrumpen el tratamiento con ravulizumab debido a efectos adversos
    efectos adversos asociados al fármaco.
    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 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 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
    LVLP (Last Visit Last Patient)
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 15
    F.1.3Elderly (>=65 years) No
    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 state1
    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
    no hay
    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 Decision2022-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-25
    P. End of Trial
    P.End of Trial StatusOngoing
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