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    Summary
    EudraCT Number:2017-004807-31
    Sponsor's Protocol Code Number:CAI001
    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:2018-11-05
    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 number2017-004807-31
    A.3Full title of the trial
    A 2-Stage, Multicenter, Randomized, Placebo-Controlled Study to Evaluate Safety/Tolerability, Pharmacokinetics, and Efficacy of UCB7858 in Adult Kidney Transplant Recipients With Chronic Allograft Injury
    Un estudio de dos etapas, multicéntrico, aleatorizado y controlado con placebo para evaluar la seguridad/tolerabilidad, la farmacocinética y la eficacia de UCB7858 en receptores adultos de un trasplante de riñón con nefropatía crónica del alotrasplante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate safety, tolerability, pharmacokinetics, and efficacy of UCB7858 in adult kidney transplant recipients with chronic allograft injury
    Un estudio para evaluar la seguridad, tolerabilidad, la farmacocinética y la eficacia de UCB7858 en receptores adultos de un trasplante de riñón con nefropatía crónica del alotrasplante
    A.4.1Sponsor's protocol code numberCAI001
    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 SponsorUCB Biopharma SPRL
    B.1.3.4CountryBelgium
    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 supportUCB Biopharma SPRL
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number003491570 06 49
    B.5.6E-mailclinicaltrials@ucb.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 nameUCB7858
    D.3.2Product code UCB7858
    D.3.4Pharmaceutical form 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 INNNot applicable
    D.3.9.2Current sponsor codeUCB7858
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Allograft Injury
    Nefropatía crónica del alotrasplante
    E.1.1.1Medical condition in easily understood language
    Chronic Allograft Injury (CAI) is a multi-factorial condition that causes gradual loss of kidney function over time, leading ultimately to end stage renal failure and loss of the transplanted kidney.
    Nefropatía crónica alotrasplante(NCA): afección multifactorial que causa pérdida gradual de función renal con el tiempo, que al final causa insuficiencia renal terminal y pérdida riñón trasplantado
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10016642
    E.1.2Term Fibrosis
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Stage 1 - To investigate the safety and tolerability of UCB7858 in kidney transplant recipients with deteriorating kidney function associated with chronic allograft injury (CAI) and to determine the dose level for Stage 2

    Stage 2 - To evaluate the safety, tolerability, and efficacy of repeat dosing with UCB7858 in kidney transplant recipients with deteriorating kidney function associated with CAI
    Etapa 1: Investigar la seguridad y la tolerabilidad de UCB7858 en los receptores de trasplantes de riñón con deterioro de la función renal asociado con nefropatía crónica del alotrasplante (NCA) y determinar el nivel de dosis para la Etapa 2.

    Etapa 2: Evaluar la seguridad, la tolerabilidad y la eficacia de la administración de dosis repetidas de UCB7858 en los receptores de trasplantes de riñón con deterioro de la función renal asociado con la NCA.
    E.2.2Secondary objectives of the trial
    To evaluate the pharmacokinetics (PK) of UCB7858 when administered as repeat doses intravenous (iv) in kidney transplant recipients with CAI and to investigate the effect of UCB7858 against other efficacy parameters
    Evaluar la farmacocinética (FC) de UCB7858 cuando se administra en dosis repetidas por vía intravenosa (i.v.) en los receptores de trasplantes de riñón con NCA e investigar el efecto de UCB7858 en relación con otros parámetros de la eficacia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Functioning 1st donor allograft >=1 year post-transplantation
    -Qualifying historical biopsy diagnosis of chronic allograft injury (CAI)
    -Baseline (screening) biopsy showing Grade II or III interstitial fibrosis/tubular atrophy (IF/TA) (>=25% IF/TA)
    -Progressive decline in kidney function defined as estimated glomerular filtration rate (eGFR) decline >=5% during the 9 months prior to screening
    -An eGFR >=30 mL/min/1.73 m2 for a period of 6 months up to screening
    -Stable standard of care concomitant medication for 3 months prior to screening
    -Subject is male or female, >=18 years of age
    - Alotrasplante de primer donante en funcionamiento >= 1 año después del trasplante
    - Diagnóstico de nefropatía crónica del alotrasplante (NCA) mediante biopsia histórica habilitante
    - Biopsia inicial (de selección) que muestra fibrosis intersticial/atrofia tubular (FI/AT) de grados II o III (>= 25 % de FI/AT)
    - Disminución progresiva de la función renal, definida como una reducción del índice de filtración glomerular estimado (TFGe) >=5 % durante los 9 meses anteriores a la selección
    - Una TFGe>=≥ 30 ml/min/1,73 m2 durante un período de 6 meses hasta el momento de la selección
    - Medicamentos concomitantes habituales estables durante los 3 meses anteriores a la selección
    - El sujeto es una persona de cualquier sexo >= 18 años de edad
    E.4Principal exclusion criteria
    -Recipient of multi-organ transplant (with the exception of dual kidney transplant recipients, and/or corneal transplant recipients)
    -Screening biopsy shows evidence of significant antibody-mediated rejection
    -Screening biopsy shows evidence of T cell-mediated rejection classified Banff Grade >=I
    -Screening biopsy shows evidence of de novo or recurrent glomerular disease
    -Screening biopsy shows severe transplant glomerulopathy lesions defined as chronic glomerulopathy (cg) score of 3
    -Proteinuria >=1500 mg/g at screening
    -Subject who has a history of biopsy-proven acute rejection or treatment for suspected acute rejection within 3 months prior to screening
    -Subject has had major surgery (including joint surgery) within 6 months prior to screening, or has planned surgery within 6 months after the last dose of IMP
    -Subject has a current diagnosis of foot ulcer or diagnosis of chronic diabetic ulcer
    -Subject has a history of wound healing complications
    -Subject has taken concomitant medication of sirolimus or everolimus within 3 months of screening
    - Receptor de un trasplante multiorgánico (con la excepción de los receptores de trasplante doble de riñón, de trasplante de córnea o de ambos trasplantes)
    - La biopsia de selección muestra indicios de rechazo significativo mediado por anticuerpos
    - La biopsia de selección muestra indicios de rechazo mediado por los linfocitos T clasificado como de grado>= I según Banff
    - La biopsia de selección muestra indicios de enfermedad glomerular nueva o recurrente
    - La biopsia de selección muestra lesiones por glomerulopatía del trasplante graves, lo que se define como una puntuación de glomerulopatía crónica (GC) de 3
    - Proteinuria >= 1500 mg/g en la selección
    - El sujeto presenta antecedentes de rechazo agudo comprobado por biopsia o ha recibido tratamiento por sospecha de rechazo agudo en los 3 meses anteriores a la selección
    - El sujeto se ha sometido a una intervención quirúrgica mayor (incluyendo cirugía articular) dentro de los 6 meses anteriores a la selección, o tiene programada una intervención quirúrgica dentro de los 6 meses siguientes a la administración de la última dosis del PEI
    - El sujeto presenta un diagnóstico actual de úlcera de pie o diagnóstico de úlcera crónica de diabético
    - El sujeto presenta antecedentes de complicaciones en la cicatrización de las heridas
    - El sujeto ha tomado sirolimús o everolimús como medicación concomitante en los 3 meses anteriores a la selección
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence of treatment-emergent adverse events (TEAEs) (Stages 1 and 2)
    2. Absolute estimated Glomerular Filtration Rate (eGFR) value (Stage 2 only)
    1. Incidencia de acontecimientos adversos surgidos durante el tratamiento (AADT) (etapas 1 y 2)
    2. Valor del índice de filtración glomerular estimado (TFGe) absoluta (solo en la etapa 2)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. From Day 1 (Baseline) to the end of Safety Follow-up (Up to Day 505 for Stage 1 and Day 449 for Stage 2)
    2. From Day 1 (Baseline) to the end of Treatment Period (Up to Day 365 for Stage 1 and Day 309 for Stage 2)
    1. Desde el día 1 (inicio) hasta el final del seguimiento de la seguridad (hasta el día 505 para la Etapa 1 y el día 449 para la etapa 2)
    2. Desde el día 1 (inicio) hasta el final del período de tratamiento (hasta el día 365 para la Etapa 1 y el día 309 para la etapa 2)
    E.5.2Secondary end point(s)
    1. Absolute estimated Glomerular Filtration Rate (eGFR) value (Stages 1 and 2, separately or combined, as appropriate)
    2. Percent of Baseline eGFR value (Stage 1 and 2, separately or combined, as appropriate)
    3. Change from Baseline in PCR (Stages 1 and 2, separately or combined, as appropriate)
    4. Time to Graft Failure (Stages 1 and 2, separately or combined, as appropriate)
    5. Pre-dose serum concentration of UCB7858 (C_trough) value (Stages 1 and 2)
    6. Serum concentration of UCB7858 at the end of infusion (C_inf) value (Stages 1 and 2)
    1. Valor del índice de filtración glomerular estimado (TFGe) absoluta (etapas 1 y 2, por separado o combinadas, según corresponda)
    2. Porcentaje del valor de la TFGe inicial (Etapas 1 y 2, por separado o combinadas, según corresponda)
    3. Cambio en la RCP desde el inicio (etapas 1 y 2, por separado o combinadas, según corresponda)
    4. Tiempo transcurrido hasta el fracaso del injerto (etapas 1 y 2, por separado o combinadas, según corresponda)
    5. Valor de la concentración sérica de UCB7858 antes de la dosis (C_mín) (etapas 1 y 2)
    6. Valor de la concentración sérica de UCB7858 al final de la infusión (C_inf) (etapas 1 y 2)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.-3. From Day 57 to the end of Treatment Period for Stage 1 (Up to Day 365) and from Day 1 to the end of Treatment Period for Stage 2 (up to Day 309)
    4. From Day 1 (Baseline) to the end of Treatment Period (Up to Day 365 for Stage 1 and Day 309 for Stage 2)
    5. and 6. From Day 1 to the end of Treatment Period for Stage 1 (Up to Day 365) and from Day 1 to the end of Treatment Period for Stage 2 (up to Day 309)
    1.-3. Desde el día 57 hasta el final del período de tratamiento para la Etapa 1 (hasta el día 365) y desde el día 1 hasta el final del período de tratamiento para la etapa 2 (hasta el día 309)

    4. Desde el día 1 (inicio) hasta el final del período de tratamiento (hasta el día 365 para la Etapa 1 y el día 309 para la etapa 2)

    5. y 6. Desde el día 1 hasta el final del período de tratamiento para la Etapa 1 (hasta el día 365) y desde el día 1 hasta el final del período de tratamiento para la etapa 2 (hasta el día 309)
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase 1/Phase 2 study. First Administration in Patients.
    Estudio en fases I/II. Primera administración en los pacientes.
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Australia
    Belgium
    Canada
    Germany
    Spain
    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
    UVUP (última visita del último paciente)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days2
    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: 132
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 state72
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 162
    F.4.2.2In the whole clinical trial 177
    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 Decision2018-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-05-04
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