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    Summary
    EudraCT Number:2015-005231-40
    Sponsor's Protocol Code Number:LEDA
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-11-04
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-005231-40
    A.3Full title of the trial
    Effect of Aspirin on renal disease progression in patients with type 2 diabetes: a multicentre double-blind, placebo-controlled, randomised trial. The LEDA (renaL disEase progression by aspirin in Diabetic pAtients) study
    Effetto dell’Aspirina sul decadimento della funzione renale in pazienti affetti da Diabete Mellito di Tipo 2: studio di intervento multicentrico randomizzato doppio cieco con aspirina versus placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Aspirin and renal function in type 2 diabetes
    Aspirina e funzione renale nel diabete
    A.3.2Name or abbreviated title of the trial where available
    Aspirin and renal function in type 2 diabetes
    Aspirina e funzione renale nel diabete
    A.4.1Sponsor's protocol code numberLEDA
    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 SponsorUMBERTO I - POLICLINICO DI ROMA
    B.1.3.4CountryItaly
    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 supportDipartimento di Medicina Interna e Specialità Medi
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDipartimento di Medicina Interna e Specialità Mediche - Sapienza Università di Roma
    B.5.2Functional name of contact pointI Clinica Medica
    B.5.3 Address:
    B.5.3.1Street AddressViale del Policlinico 155
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00161
    B.5.3.4CountryItaly
    B.5.4Telephone number064461933
    B.5.5Fax number0649972309
    B.5.6E-maildaniele.pastori@uniroma1.it
    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 CARDIOASPIRIN - 100 MG COMPRESSE GASTRORESISTENTI30 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameCardioaspirin
    D.3.2Product code [NA]
    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 INNACIDO ACETILSALICILICO
    D.3.9.2Current sponsor codeN/A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 2 diabetes
    Diabete mellito di tipo 2
    E.1.1.1Medical condition in easily understood language
    Diabetes
    Diabete
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10012594
    E.1.2Term Diabetes
    E.1.2System Organ Class 100000004861
    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 the relationship between progression of renal failure and aspirin use in patients suffering from type 2 diabetes
    Valutare la relazione tra progressione della funzione renale ed uso di aspirina in pazienti affetti da diabete mellito
    E.2.2Secondary objectives of the trial
    To evaluate the relationship between urinary excretion of thromboxane B2 and changes in renal function
    Valutare la relazione tra l’escrezione urinaria del trombossano B2 e i cambiamenti della funzione renale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age =35 years
    - Diagnosis of type 2 diabetes:
    - random blood glucose = 200 mg / dl (=11.1 mmol/l)
    - fasting blood glucose = 126 mg/dl (=7.0 mmol/l). Fasting is defined as no caloric intake for at least 8 h.*
    - blood glucose 2 hours after oral glucose tolerance test (75 g OGTT) =200 mg/dl. The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water.*
    - hemoglobin A1c = 6.5% (= 48 mmol/mol). The test should be performed in a laboratory using a method that is NGSP certified and standardized to the DCCT assay.*
    - treatment with any glucose-lowering agent.
    - Età =35 anni
    - Diagnosi di DM2 (29; 30):
    o Glicemia casuale = 200 mg/dl (=11.1 mmol/l);
    o Glicemia a digiuno = 126 mg/dl (=7.0 mmol/l). Il digiuno è definito come assenza di introito calorico da almeno 8h;
    o Glicemia a 2 ore dal carico orale di glucosio (OGTT, 75 gr) =200 mg/dl, assunzione di farmaci ipoglicemizzanti. Il test OGTT dovrà essere eseguito in accordo alle raccomandazioni dell’Organizzazione Mondiale della Sanità;
    o Emoglobina glicata =6.5% (= 48 mmol/mol);
    o Trattamento con farmaci ipoglicemizzanti.
    E.4Principal exclusion criteria
    1) History of cardiovascular or cerebrovascular events (defined on history and/or instrumental findings provided by the patient);
    2) Presence of inadequate glycemic control (i.e., hemoglobin A1c =8%)
    3) Presence of uncontrolled blood pressure despite anti-hypertensive treatment (=140/=85 mmHg)
    4) Previous major bleeding (i.e. intracranial)
    5) Previous gastro-intestinal ulcer
    6) Clinical diagnosis of type 1 diabetes (diagnosis of diabetes and insulin use before 35 years of age);
    7) Patients with chronic kidney disease G4 or G5 stage (i.e., eGFR <30 ml/min/1.73 m2 or dialysis);
    8) Chronic active infections or
    9) Evidence of malignancy in the last 5 years. Patients with in situ neoplastic disease successful treated only with local excision can be included in the study (including in situ non-melanoma skin cancer).
    10) Autoimmune systemic diseases;
    11) Sustained cardiac arrhythmias requiring anticoagulant treatment (i.e. atrial fibrillation). In this category isolated ventricular/supraventricular extra-systoles are not included;
    12) Use of non-steroidal anti-inflammatory drugs, or other antiplatelet agents in the previous 30 days;
    13) Cirrhosis of any etiology
    14) Use of anticoagulants;
    15) Life expectancy <1 year;
    16) Known allergy to aspirin;
    17) Known pregnancy;
    18) Severe psychiatric illness.
    1) Storia di eventi cardiovascolari o cerebrovascolari (definiti su base anamnestica e/o strumentale);
    2) Presenza di scompenso glicemico (emoglobina glicata =8%);
    3) Presenza di ipertensione arteriosa non controllata nonostante trattamento antipertensivo (PA =140/=85 mmHg)(29; 31);
    4) Pazienti pregressa storia di sanguinamento maggiore (secondo i criteri ISTH 2005)(32);
    5) Pazienti con storia di ulcera gastroduodenale;
    6) Diagnosi di diabete mellito di tipo 1 (diagnosi di diabete ed uso di insulina prima dei 35 anni di età);
    7) Pazienti con insufficienza renale in stadio G4 o G5 (VFG <30 ml/min o dialisi) al basale;
    8) Infezione cronica attiva o
    9) Evidenza di neoplasia negli ultimi 5 anni: si possono includere nello studio pazienti con neoplasia in situ trattata efficacemente con la sola asportazione chirurgica locale (incluse neoplasie in situ non-melanoma);
    10) Presenza di malattie autoimmuni sistemiche;
    11) Presenza di trapianto d’organo o di midollo osseo;
    12) Aritmia cardiaca sostenuta che richieda trattamento anticoagulante (ad es. fibrillazione atriale). Non rientrano in questa categoria i pazienti con extrasistolia ventricolare/sopraventricolare non significativa;
    13) Uso di farmaci anti-infiammatori non steroidei, o altri farmaci antipiastrinici nei precedenti 30 giorni;
    14) Cirrosi epatica di qualsiasi eziologia;
    15) Uso di farmaci anticoagulanti;
    16) Aspettativa di vita <1 anno;
    17) Allergia nota all’aspirina;
    18) Stato di gravidanza al momento dell’arruolamento;
    19) Presenza di patologia psichiatrica grave (tale da compromettere l’aderenza al trattamento).
    E.5 End points
    E.5.1Primary end point(s)
    The aim of our study is to evaluate the decline of renal function in diabetic patients treated with aspirin 100 mg/day vs. placebo. In particular, we will evaluate:
    - The absolute change in eGFR, calculated as the difference between eGFR at 12 months - baseline eGFR;
    - The rapid decline in renal function, defined as a reduction of eGFR =5 ml/min at 1 years.
    - The change of renal function class (from G1 to G2, from G2 to G3a and so on) at 6 and 12 months.
    valutare il declino della funzionalità renale in pazienti diabetici trattati con aspirina 100 mg/die vs. placebo. In particolare verrà valutato:
    - Il cambiamento assoluto della VFG, calcolata come differenza tra la VFG a 12 mesi – VFG basale;
    - Il declino rapido della funzione renale, definito come un peggioramento ad un anno =5 ml/min della VFG;
    - Il cambiamento di classe di funzionalità renale (da G1 a G2, da G2 a G3a e così via) a 6 e 12 mesi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months and 1 year
    6 mesi ed 1 anno
    E.5.2Secondary end point(s)
    As secondary endpoint, we will evaluate changes in the urinary excretion TxB2 both baseline and at one year. Changing levels of urinary TxB2 will then be related to renal function.
    Per tutti i pazienti verrà raccolto un campione di urine per l’analisi dell’escrezione urinaria del TxB2 sia al basale che ad un anno. I cambiamenti nei livelli di escrezione urinaria di TxB2 verranno quindi correlati alla funzionalità renale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months and 1 year
    6 mesi ed 1 anno
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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) Yes
    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 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 concerned9
    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 Information not present in EudraCT
    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
    1 year enrolment. After the last enrolment, there will be 1 year of treatment.
    1 anno di arruolamento. dopo l'ultimo paziente arruolato alla fine di questo anno, segue 1 anno di trattamento.
    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 months0
    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 months0
    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: 209
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 209
    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 state418
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 418
    F.4.2.2In the whole clinical trial 418
    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)
    Patients will be followed up after the ending of the study to assess the onset of late adverse effect.
    I pazienti continueranno ad esssere seguiti per la loro patologia di base e per verificare l'insorgenza di effetti avversi tardivi.
    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 Decision2017-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-12
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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