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    Summary
    EudraCT Number:2019-004154-28
    Sponsor's Protocol Code Number:TED16414
    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:2019-12-20
    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 number2019-004154-28
    A.3Full title of the trial
    A Phase 1b/2 study to evaluate the safety, pharmacokinetics, and preliminary efficacy of isatuximab (SAR650984) in patients awaiting kidney transplantation
    Estudio de fase 1b/2 para evaluar la seguridad, la farmacocinética y la eficacia preliminar de isatuximab (SAR650984) en pacientes en espera de trasplante renal
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety, pharmacokinetics, and preliminary efficacy of isatuximab in patients awaiting kidney transplantation
    Seguridad, farmacocinética y eficacia preliminar de isatuximab (SAR650984) en pacientes en espera de trasplante renal
    A.4.1Sponsor's protocol code numberTED16414
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1238-9716
    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 SponsorSanofi-Aventis Recherche & Développement
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSanofi-Aventis Recherche & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis, s.a.
    B.5.2Functional name of contact pointUnidad de Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla 2, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number+34934859400
    B.5.6E-mailes-unidadestudiosclinicos@sanofi.com
    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 No
    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 nameisatuximab
    D.3.2Product code SAR650984
    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 INNisatuximab
    D.3.9.2Current sponsor codeSAR650984
    D.3.9.4EV Substance CodeSUB119676
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) No
    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
    (Patients awaiting) kidney transplantation
    (Pacientes en espera de) trasplante renal
    E.1.1.1Medical condition in easily understood language
    Kidney transplantation
    Trasplante renal
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10021425
    E.1.2Term Immune system disorder
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Phase 1: To characterize the safety and tolerability of isatuximab in kidney transplant candidates.
    - Phase 2: To evaluate the efficacy of isatuximab in desensitization of patients awaiting kidney transplantation.
    - Fase 1: Caracterizar la seguridad y tolerabilidad de isatuximab en candidatos a trasplante renal.
    - Fase 2: Evaluar la eficacia de isatuximab para desensibilizar a los pacientes que esperan un trasplante renal.
    E.2.2Secondary objectives of the trial
    - Phase 2: To characterize the safety profile of isatuximab in kidney transplant candidates.
    - To characterize the pharmacokinetic (PK) profile of isatuximab in kidney transplant candidates.
    - To evaluate the immunogenicity of isatuximab.
    -To assess the overall efficacy of isatuximab in desensitization of patients awaiting kidney transplantation.
    - Fase 2: Caracterizar el perfil de seguridad de isatuximab en candidatos a trasplante renal.
    - Caracterizar el perfil farmacocinético (FC) de isatuximab en candidatos a trasplante renal.
    - Evaluar la inmunogenicidad de isatuximab.
    - Evaluar la eficacia global de isatuximab para desensibilizar a los pacientes que esperan un trasplante renal.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participant must be 18 to 70 years of age
    - Diagnosis of chronic kidney disease (CKD) and active candidate on the kidney donor waitlist at the time of screening.
    - Body mass index (BMI) ≤40 kg/m2.
    - Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    - Capable of giving signed informed consent.
    For Participants in Cohort A: active candidates on the kidney waitlist with living donor.
    For participants in Cohort B: active candidates on the kidney waitlist with no living donor cleared for donation.
    - El participante debe tener de 18 a 70 años
    - Diagnóstico de Enfermedad Renal Crónica y candidato activo en la lista de espera de riñón en el momento de la selección
    - Índice de masa corporal (IMC) ≤40 kg/m2
    - El uso de anticonceptivos en los hombres o mujeres debe ser de acuerdo con las regulaciones locales en referencia a los métodos anticonceptivos para participantes en estudios clínicos
    - Capaz de dar el consentimiento informado firmado
    Para los participantes de la Cohorte A: candidato activo en la lista de espera de riñón con donante vivo declarado para la donación.
    Para los participantes de la Cohorte B: candidato activo en la lista de espera de riñón sin donante vivo declarado para la donación.
    E.4Principal exclusion criteria
    - Significant cardiac dysfunction
    - Known active, recurrent, or chronic infection
    - Active lupus or uncontrolled diabetes
    - Prior treatment with rituximab within 6 months from SAR650984 administration
    - Inadequate organ and bone marrow function at screening
    - Pregnant or breastfeeding women or women who intend to become pregnant during participation in the study
    - Known intolerance or hypersensitivity to any component of SAR650984 or premedications
    - Participants who are not suitable for participation as judged by the Investigator
    - Disfunción cardíaca significativa
    - Infección activa, recurrente o crónica conocida
    - Participantes con lupus activo o diabetes mal controlada
    - Tratamiento recibido con rituximab en los 6 meses desde el inicio de la administración del producto en investigación (SAR650984).
    - Funciones inadecuadas de los órganos o la médula ósea en la visita de selección
    - Mujeres embarazadas o amamantando o mujeres que tienen intención de quedarse embarazadas durante la participación en el estudio
    - Intolerancia conocida o hipersensibilidad a alguno de los componentes de isatuximab o premedicaciones.
    - Participantes no adecuados para participar según el criterio del investigador
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1 AEs/ SAEs and laboratory abnormalities - List of Adverse events (AEs)/serious adverse events (SAEs), laboratory abnormalities during Phase 1 period.
    Phase 2: Response rate - Proportion of participants meeting at least one of the predefined efficacy criteria as measured by single antigen bead assay.
    - Fase 1: Acontecimientos adversos (AA)/acontecimientos adversos graves (AAG) y valores analíticos anómalos
    - Fase 2: Tasa de respuesta (TR) - proporción de participantes que cumplen al menos uno de los criterios predefinidos de eficacia medida mediante un ensayo de un solo antígeno (SAB)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase 1 - Up to 30 days after last study treatment
    Phase 2 - Baseline to 26 weeks after last study treatment
    Fase 1 - Hasta 30 días después del período de tratamiento
    Fase 2 - Desde el inicio hasta 26 semanas después del período de tratamiento
    E.5.2Secondary end point(s)
    1. Proportion of participants with AEs/SAEs/laboratory abnormalities.
    2. Concentration of SAR650984 observed at the end of intravenous infusion.
    3. Maximum concentration of SAR650984 observed after the first infusion.
    4. Time to reach Cmax
    5. Last concentration observed above the lower limit of quantification after the first infusion.
    6. Time of Clast
    7. Concentration observed just before treatment administration during repeated dosing.
    8. Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval T (168 hours)
    9. Proportion of participants with anti-drug antibodies (ADA) against isatuximab.
    10. Duration of time the response lasts from when achieved.
    11. Proportion of participants who achieved target calculated panel reactive antibodies (cPRA).
    12. Duration of time the target cPRA lasts from when achieved
    13. Number of anti-HLA-antibody reduced to below positivity cutoff as measured in a SAB assay. Abbreviations: HLA = human leukocyte antigen, SAB = single antigen bead
    14. Time from baseline to when participant received first transplant offer, if applicable.
    15. Time from wait listed to transplant surgery, if applicable.
    16. Number of transplant offers received for each participant, if applicable.
    17. Proportion of participants who experienced any antibody mediated rejection (AMR), if applicable.
    18. Time from transplant surgery to first episode of AMR, if applicable.
    19. Proportion of participants with graft survival at 6 month post-transplant surgery, if applicable.
    1. Proporción de participantes con AA/AAG y valores analíticos anormales.
    Parámetros FC de isatuximab:
    2. Concentración de SAR650984 observada al final de la infusión intravenosa.
    3. Concentración máxima observada después de la primera infusión.
    4. Tiempo para alcanzar la C max
    5. Última concentración observada por encima del límite inferior de cuantificación después de la primera perfusión.
    6. Tiempo de C last
    7. Concentración observada justo antes de la administración del tratamiento durante la administración repetida.
    8. Área bajo la curva de concentración plasmática versus tiempo calculado usando el método trapezoidal sobre la dosificación intervalo T (168 horas)
    9. Incidencia de anticuerpos antifármaco (AAF) contra isatuximab.
    10. Duración del tiempo que dura la respuesta desde que se alcanza.
    11. Proporción de participantes que logran el panel reactivo de anticuerpos calculado (cPRA) objetivo.
    12. Número de anticuerpos anti-HLA con MFI inicial ≥ 3000 reducido a < 2000 medido en un ensayo SAB según la evaluación del laboratorio central. Abreviaturas: HLA = antígeno leucocitario humano, SAB = ensayo de un solo antígeno
    14. Tiempo desde el inicio hasta la primera oferta de trasplante, si corresponde.
    15. Tiempo desde lista de espera hasta el trasplante, si corresponde.
    16. Número de ofertas de trasplante por paciente, si corresponde.
    17. Tasa de rechazo mediado por anticuerpos (RMA): proporción de participantes que experimentaron cualquier RMA, si procede.
    18. Tiempo hasta el primer episodio de RMA, si procede.
    19. Proporción de participantes con supervivencia del injerto a los 6 meses después del trasplante, si procede.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to 30 days after last study treatment (LST)
    2. Baseline up to 1 week after first study treatment (FST)
    3. Baseline up to 1 week after FST
    4. Baseline up to 1 week after FST
    5. Baseline up to 1 week after FST
    6. Baseline up to 1 week after FST
    7. Baseline to end of treatment
    8. Baseline up to 1 week after FST
    9. Baseline to 9 weeks after LST
    10. Baseline to 26 weeks after LST
    11. Baseline to 26 weeks after LST
    12. Baseline to 26 weeks after LST
    13. Baseline to 26 weeks after LST
    14. Up to 26 weeks after the last participant completed treatment period (LPCTP)
    15. Up to 26 weeks after the LPCTP
    16. Up to 26 weeks after the LPCTP
    17. Up to 26 weeks after the LPCTP
    18. Up to 26 weeks after the LPCTP
    19. Up to 26 weeks after the LPCTP
    1. Hasta 30 días después del período de tratamiento
    2. - 6. Desde el inicio hasta 1 semana tras el primer tratamiento del estudio
    7. Desde el inicio hasta fin de tratamiento
    8. Desde el inicio hasta primer tratamiento del estudio
    9. Desde el inicio hasta 9 semanas después del período de tratamiento
    10. - 13. Desde el inicio hasta 26 semanas después del período de tratamiento
    14. - 19. Hasta 26 semanas después del último paciente que completó el período de tratamiento
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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.8.2.4Number of treatment arms in the trial3
    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 concerned2
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Spain
    United States
    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 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 months6
    E.8.9.1In the Member State concerned days12
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days12
    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: 19
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 17
    F.4.2.2In the whole clinical trial 42
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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