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    Summary
    EudraCT Number:2011-006162-40
    Sponsor's Protocol Code Number:NODAT-BELATAC
    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:2013-03-06
    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 number2011-006162-40
    A.3Full title of the trial
    NEW-ONSET DIABETES MELLITUS AFTER RENAL TRANSPLANTATION. A MULTICENTRE, PROSPECTIVE, RANDOMIZED, OPEN STUDY TO EVALUATE BELATACEPT-BASED VERSUS TACROLIMUS-BASED IMMUNOSUPPRESSION
    Diabetes mellitus de novo después del trasplante renal. Un estudio abierto, multicéntrico, prospectivo y randomizado para comparar un régimen inmunosupresor basado en tacrolimus respecto a un régimen basado en belatacept
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NEW-ONSET DIABETES MELLITUS AFTER RENAL TRANSPLANTATION. STUDY TO EVALUATE BELATACEPT-BASED VERSUS TACROLIMUS-BASED IMMUNOSUPPRESSION
    Diabetes mellitus de nuevo diagnóstico después del trasplante renal. Estudio para comparar un régimen inmunosupresor basado en tacrolimus respecto a un régimen basado en belatacept
    A.4.1Sponsor's protocol code numberNODAT-BELATAC
    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 SponsorFundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
    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 supportVHIR
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr Francesc Moreso Mateos. Hospital Vall d?Hebron/Department of Nephrology
    B.5.2Functional name of contact pointStudy coordinator
    B.5.3 Address:
    B.5.3.1Street AddressPaseo Vall d'Hebron 119-129
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number+34932746079
    B.5.5Fax number+34934894102
    B.5.6E-mailfjmoreso@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 NULOJIX
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    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 Powder for 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 INNBelatacept
    D.3.9.1CAS number 706808-37-9
    D.3.9.3Other descriptive nameBELATACEPT
    D.3.9.4EV Substance CodeSUB20603
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Adult kidney transplant recipients older than 45 years old with risk of developing prediabetes states after renal transplantation (PREDAT) and diabetes mellitus after renal transplantation (NODAT)
    Paientes adultos receptores de un trasplante renal mayores de 45 años con riesgo de desarrollar estado prediabético después del trasplante renal (PREDAT) y diabetis mellitus después del trasplante renal (NODAT)
    E.1.1.1Medical condition in easily understood language
    Adult kidney transplant recipients older than 45 years old with risk of developing prediabetes y diabetes mellitus after renal transplantation
    Pacientes adultos receptores de un trasplante renal mayores de 45 años con riesgo de desarrollar prediabetes o diabetes después del trasplante renal
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level HLGT
    E.1.2Classification code 10018424
    E.1.2Term Glucose metabolism disorders (incl diabetes mellitus)
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10023438
    E.1.2Term Kidney transplant
    E.1.2System Organ Class 100000004865
    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 compare the incidence of glucose metabolism alterations defined as per the American Diabetic Association at any time point up to 6 months after kidney transplantation
    El objetivo principal es comparar la incidencia de alteraciones del metabolismo de la glucosa según la American Diabetic Association, en cualquier punto de tiempo hasta 6 meses después del trasplante renal
    E.2.2Secondary objectives of the trial
    Acute rejections by signs and symptoms
    Biopsy confirmed acute rejections
    Patient survival at 6 months.
    Graft survival at 6 months.
    Renal function at 6 months measured as estimated glomerular filtration rate according to MDRD-4 formula.
    Reported quality of life
    Rechazo agudo por signos y síntomas
    Rechazo agudo confirmado por biopsia
    Supervivencia del paciente a los 6 meses.
    Supervivencia del injerto a los 6 meses.
    Función renal a los 6 meses medido como la tasa de filtración glomerular estimada de acuerdo a la fórmula MDRD-4.
    Calidad de vida
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age ? 45 years of age.
    Patients with high-risk of GMA after renal transplantation defined as:
    a) Patients aged ? 60 years.
    b) Patients aged ? 45 accomplishing one of the following combinations:
    b.1) Serum triglycerides > 200 mg/ml.
    b.2) The combination of body mass index (BMI) > 27 kg/m2 and serum triclycerides > 150 mg/ml.
    b.3) The combination of serum triglycerides > 150 mg/ml and serum HDL-cholesterol < 50 mg/ml in women or < 40 mg/ml in men.
    End stage kidney disease and a suitable candidate for primary kidney transplantation or re-transplantation in who according to investigator criteria steroids may be withdrawn at 5 days.
    Receiving a kidney transplant from a deceased or living (non HLA identical) donor with compatible AB0 blood type.
    Absence of Diabetes Mellitus diagnose prior to transplantation Negative serology for hepatitis B and C virus.
    Positive serology (VCA) for EBV infection.
    Hombres y mujeres de edad ? 45 años.
    Pacientes con elevado riesgo de presentar alteraciones del metabolismo de la glucosa tras el trasplante definido como sigue:
    a) Pacientes con edad ? 60 años.
    b) Pacientes con edad ? 45 años que cumplan al menos una de las siguientes combinaciones:
    b.1) Triglicéridos > 200 mg/ml.
    b.2) La combinación índice de masa corporal (IMC) > 27 kg/m2 y triglicéridos > 150 mg/ml.
    b.3) La combinación triglicéridos > 150 mg/ml y HDL-colesterol < 50 mg/ml en mujeres o < 40 mg/ml en hombres.
    b.4.) HbA1c > 5.5% y < 6.5%.
    b.5.) la combianción de HbA1c > 5.2% y triglicéridos > 150 mg/dl o IMC > 27 kg/m2.

    Pacientes con enfermedad renal crónica terminal candidatos a primer trasplante renal o re-trasplante en los que a juicio del investigador se puedan retirar los corticoides al 5º día. Los pacientes con pérdida de un injerto previo por razones inmunológicas no serán incluidos.
    Receptores de un trasplante renal de donante cadáver o donante vivo (no HLA-idéntico) con grupo sanguíneo ABO compatible.
    Ausencia de diabetes mellitus antes del trasplante (bien tratados con medicación o controlados con dieta) o cuando haya evidencia de un test de tolerancia oral a la glucosa previo patológico o diabetes gestacional o una hemoglobina glicosilada ? 6.5mmol/L o una glucemia basal en ayunas > 100 mg/dL.
    Serología negativa para virus de la hepatitis B y C.
    Serología positiva para la infección por virus de Ebstein-Barr (VCA).
    E.4Principal exclusion criteria
    Seronegative or unknown EBV serostatus
    Patients with tuberculosis who have not been treated for latent infection.
    Patients at high risk for polyoma virus-associated nephropathy, which is mostly due to BK virus infection.
    Receiving or having previously received an organ transplant other than a kidney.
    Recipient of dual kidney transplantation.
    Recipient of a graft from a non-heart-beating donor.
    Cold ischemia time of the donor kidney > 30 hours.
    PRA >30%.
    Significant liver disease
    Serología para el virus de Ebstein-Barr negativa o desconocida.
    Pacientes con tuberculosis que no han sido tratados para infección latente.
    Pacientes con elevado riesgo de nefropatía por polioma virus BK.
    Pacientes que vayan a recibir o hayan recibido trasplante de otro órgano no renal.
    Receptores de un trasplante renal dual.
    Receptores de un trasplante procedente de un donante en asistolia.
    Tiempo de isquemia fría del injerto renal > 30 horas.
    PRA > 30%.
    Enfermedad hepática significativa
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of GMA, either PREDAT or NODAT, defined as per ADA criteria
    Incidencia de alteraciones del metabolismo de la glucosa
    E.5.1.1Timepoint(s) of evaluation of this end point
    the first 6 months after transplantation
    los primeros 6 meses del trasplante
    E.5.2Secondary end point(s)
    Acute rejections by signs and symptoms
    Biopsy confirmed acute rejections
    Patient survival at 6 months.
    Graft survival at 6 months.
    Renal function at 6 months measured as estimated glomerular filtration rate according to MDRD-4 formula.
    Reported quality of life
    Rechazo agudo por signos y síntomas
    Rechazo agudo confirmado por biopsia
    Supervivencia del paciente a los 6 meses.
    Supervivencia del injerto a los 6 meses.
    Función renal a los 6 meses medido como la tasa de filtración glomerular estimada de acuerdo a la fórmula MDRD-4.
    Calidad de vida
    E.5.2.1Timepoint(s) of evaluation of this end point
    the first 6 months after transplantation
    los primeros 6 meses del trasplante
    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 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) Yes
    E.8.2.2Placebo No
    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 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 concerned12
    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
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 90
    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
    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 Decision2013-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-12-19
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