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    Summary
    EudraCT Number:2018-003936-62
    Sponsor's Protocol Code Number:PRONE
    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:2019-04-12
    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 number2018-003936-62
    A.3Full title of the trial
    RENINE ANGIOTENSINE SYSTEM BLOCKADE (RAAS) IN RENAL TRANSPLANT RECIPIENTS WITH RENAL PROGENITOR CELLS (PEC's) IN URINE: RANDOMIZED CLINICAL TRIAL
    BLOQUEO DEL SISTEMA RENINA ANGIOTENSINA (SRAA) EN PACIENTES TRASPLANTADOS RENALES CON P'RESENCIA DE CÉLULAS PROGENITORAS RENALES (PEC's) EN ORINA: ENSAYO CLÍNICO ALEATORIZADO.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    VALSARTAN TREATMENT COMPARED IN RENAL TRANSPLANT RECIPIENTS WITH SIGNS OF POST TRANSPLANT GLOMERULOPATHY
    TRATAMIENTO CON VALSARTÁN EN PACIENTES TRASPLANTADOS RENALES CON SIGNOS DE GLOMERULOPATÍA POST TRASPLANTE
    A.4.1Sponsor's protocol code numberPRONE
    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 SponsorHOSPITAL UNIVERSITARI DE BELLVITGE-IDIBELL
    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 supportINSTITUTO DE SALUD CARLOS III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHOSPITAL UNIVERSITARI DE BELLVITGE- IDIBELL
    B.5.2Functional name of contact pointCAROLINA POLO
    B.5.3 Address:
    B.5.3.1Street AddressFEIXA LLARGA, S/N, PLANTA 3 DIÁLISIS
    B.5.3.2Town/ cityL'HOSPITALET DE LLOBREGAT
    B.5.3.3Post code08907
    B.5.3.4CountrySpain
    B.5.4Telephone number+34932607385
    B.5.5Fax number+34932607690
    B.5.6E-mailcpolo@idibell.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.2.1.2Country 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 Tablet
    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 INNVALSARTAN
    D.3.9.1CAS number 137862-53-4
    D.3.9.3Other descriptive namevalsartan
    D.3.9.4EV Substance CodeSUB00017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number80
    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
    POST TRANSPLANT RENAL GLOMERULOPATHY
    GLOMERULOPATÍA RENAL POST TRASPLANTE
    E.1.1.1Medical condition in easily understood language
    CHRONIC RENAL IMPAIRMENT AFTER RENAL TRANSPLANTATION
    DAÑO RENAL CRÓNICO TRAS EL 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 10038533
    E.1.2Term Renal transplant
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10063210
    E.1.2Term Transplant glomerulopathy
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess whether treatment with an angiotensin II receptor antagonist (AIIRA) prevents the fall of glomerular filtration in the subgroup of kidney transplant patients with presence of PECs in urine.
    Evaluar si el tratamiento con un antagonista del receptor de angiotensina II (ARAII) previene la caída del filtrado glomerular en el subgrupo de pacientes trasplantados renales con presencia de PECs en orina.
    E.2.2Secondary objectives of the trial
    1. Compare the SN-GFR (nephron glomerular filtration rate)
    2. Carry out single cell RNA sequencing studies using cell microdissection techniques of PEC cells isolated from renal biopsies performed at 6 and 24 m after transplantation in patients without uPECs and in patients with uPECs included in the therapeutic intervention study. These studies will allow us to know the changes of gene expression in PECS cells that can be associated with the favorable response in treated or untreated patients.
    3. To determine the influence of the treatment on podocyturia and the preservation of the number of podocytes at 2 years post transplant.
    4. Evaluate the influence of treatment on patient survival, graft, eGFR and proteinuria.
    5. Evaluate the influence of treatment on chronic glomerular lesions.
    6. Evaluate the safety of the treatment by recording RAGIs (serious and unexpected adverse reactions) and rate of treatment discontinuations.
    1. Comparar el SN-GFR (filtrado glomerular por nefrona)
    2. Realizar estudios de “single cell RNA sequencing” mediante técnicas de microdisección celular de células PECs aisladas de biopsia renalesa los 6 y 24 m del trasplante en pacientes sin uPECs y en pacientes con uPECs incluidos en el estudio de intervención terapéutica. Estos estudios nos permitirán conocer los cambios de expresión génica en las células PECS que se puedan asociar a la respuesta favorable en los pacientes tratados o sin tratar.
    3. Determinar la influencia del tratamiento en la podocituria y la preservación del número de podocitos a los 2 años post trasplante.
    4. Evaluar la influencia del tratamiento en la supervivencia del paciente, del injerto, eGFR y proteinuria.
    5. Evaluar la influencia del tratamiento sobre las lesiones glomerulares crónicas.
    6. Evaluar la seguridad del tratamiento mediante registro de RAGIs (reacciones adversas graves e inesperadas) y tasa de discontinuaciones del tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Written informed consent
    Stable renal function understood as a variation of eGFR of less than 15% in the last 3 months
    Immunosuppression maintenance based on tacrolimus and MMF / MPA
    Consentimiento informado por escrito
    Función renal estable entendida como variación del eGFR de menos del 15% en los últimos 3 meses
    Inmunosupresión de mantenimiento basada en tacrolimus y MMF/MPA
    E.4Principal exclusion criteria
    Chronic active infection by HCV, HBV, HIV.
    Treatment with inhibitors of the renin angiotensin system.
    Double kidney transplant or combined with another organ.
    Immunosuppression of maintenance other than tacrolimus and MMF / MPA.
    eGFR <20 ml / min / 1.73m2.
    History of allergy or intolerance to inhibitors of the renin angiotensin system.
    Physically fertile women who plan to become pregnant, are pregnant and / or breast-feeding, or who do not want to use effective contraception during their participation in the study.
    Any other medical condition that, in the opinion of the investigator, based on the counting or review of clinical records, could affect the completion of the study, including, but not limited to, visual problems or cognitive impairment.
    eGFR <20 ml / min / 1.73m2.
    History of allergy or intolerance to inhibitors of the renin angiotensin system.
    Infección crónica activa por VHC, VHB, HIV.
    Tratamiento con inhibidores del sistema renina angiotensina.
    Trasplante renal doble o combinado con otro órgano.
    Inmunosupresión de mantenimiento distinta a tacrolimus y MMF/MPA.
    eGFR <20 ml/min/1.73m2.
    Antecedente de alergia o intolerancia a los fármacos inhibidores del sistema renina angiotensina.
    Mujeres físicamente fértiles que tengan previsto quedarse embarazadas, estén embarazadas y/o en periodo de lactancia, o bien que no deseen utilizar un método anticonceptivo eficaz durante su participación en el estudio.
    Cualquier otra condición médica que, a juicio del investigador, basándose en el recuento o en la revisión de historiales clínicos, podría afectar a la finalización del estudio, incluyendo, pero no limitado a, problemas visuales o deterioro cognitivo.
    eGFR <20 ml/min/1.73m2.
    Antecedente de alergia o intolerancia a los fármacos inhibidores del sistema renina angiotensina.
    E.5 End points
    E.5.1Primary end point(s)
    The main variable will be glomerular filtration rate (GFR) 24 months after transplantation in patients treated with valsartan compared to the group without medication. The measurement of GFR will be carried out by means of iohexol clearance.
    La variable principal será el Filtrado glomerular (GFR) a los 24 meses del trasplante en pacientes tratados con valsartán en comparación al grupo sin medicación. La medida del GFR se realizará mediante aclaramiento de iohexol.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    24 meses
    E.5.2Secondary end point(s)
    1. STUDY OF THE SINGLE-CELL RNA SEQUENCING
    2. CALCULATING THE SN-GFR (GFR for nephron):
    • CALCULATION OF THE RENAL CORTICAL VOLUME.
    • MORPHOMETRIC AND STEREOLOGICAL STUDY OF RENAL BIOPSY.
    • CALCULATION OF THE TOTAL NUMBER OF NEPHRON AND SNGFR.
    3. ANALYSIS OF PODOCYTURY AND ESTIMATION OF PODOCYTES IN RENAL BIOPSY.
    4. PROTEINURIA, eGFR, SURVIVAL OF THE GRAFT AND THE PATIENT
    5. ANALYSIS OF RENAL BIOPSIES
    6. EVALUATION OF SAFETY PARAMETERS
    1. ESTUDIO DEL SINGLE-CELL RNA SEQUENCING
    2. CÁLCULO EL SN-GFR (GFR por nefrona):
    • CÁLCULO DEL VOLUMEN CORTICAL RENAL.
    • ESTUDIO MORFOMÉTRICO Y ESTEREOLÓGICO DE LA BIOPSIA RENAL.
    • CÁLCULO DEL NÚMERO TOTAL DE NEFRONAS Y DEL SNGFR.
    3. ANÁLISIS DE PODOCITURIA Y ESTIMACIÓN DE PODOCITOS EN LA BIOPSIA RENAL.
    4. PROTEINURIA, eGFR, SUPERVIVENCIA DEL INJERTO Y DEL PACIENTE
    5. ANÁLISIS DE LAS BIOPSIAS RENALES
    6. EVALUACIÓN DE PARÁMETROS DE SEGURIDAD
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 months
    24 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    grupo sin tratamiento
    no treatment group
    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 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
    LPLV
    LPLV
    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
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state180
    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 Decision2019-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-06
    P. End of Trial
    P.End of Trial StatusOngoing
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