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    The EU Clinical Trials Register currently displays   43936   clinical trials with a EudraCT protocol, of which   7310   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2006-004702-56
    Sponsor's Protocol Code Number:NN1630-1453
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-11-09
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2006-004702-56
    A.3Full title of the trial
    Outcome Trial Evaluating the Efficacy and Safety of Norditropin in Adult Patients on Chronic Haemodialysis A Randomised, Double-blind, Parallel group, Placebo controlled, Multi-centre trial
    Studio clinico finalizzato a valutare l`efficacia e la sicurezza del Norditropin in pazienti adulti in emodialisi cronica. Studio randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli, multicentrico.
    A.4.1Sponsor's protocol code numberNN1630-1453
    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 SponsorNOVO NORDISK
    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 support
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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. of the Marketing Authorisation holderNOVO NORDISK FARMACEUTICI SpA
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSomatropin
    D.3.9.1CAS number 12629-01-5
    D.3.10 Strength
    D.3.10.1Concentration unit µg/kg microgram(s)/kilogram
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    D. medicinal product typeNon Applicabile
    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 injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adult Patients in Chronic Dialysis (APCD)
    Pazienti Adulti in Dialisi Cronica
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10018875
    E.1.2Term Haemodialysis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective: To evaluate and establish the effect of Norditropin (somatropin) on mortality in adult patients onchronic haemodialysis
    Obiettivo primario: Valutare e determinare l'effetto di Norditropin (somatropina) sulla mortalita' nei pazienti adulti in emodialisi cronica
    E.2.2Secondary objectives of the trial
    Secondary objectives: To evaluate and establish • The effect of growth hormone on morbidity, Health Related Quality of Life (HRQoL) and other variables in APCD • The safety of growth hormone in APCD
    Obiettivi secondari Valutare e determinare: • l'effetto dell'ormone della crescita su morbilita',qualita' della vita correlata alla salute (HRQoL) e su altre variabili nei pazienti APCD; • la sicurezza dell'ormone della crescita nei pazienti APCD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the subject). 2. Male or female on chronic (&#8805; 3 months prior to screening) in-centre haemodialysis (including all types of haemodialysis: e.g., short daily, nocturnal, etc.), age &#8805; 18 3. Serum albumin < 40 g/L (median of three measurements analysed by a central laboratory) 4. Stable (&#8805; 3 months) and adequate haemodialysis treatment, as defined by no less than 3 consecutive monthly spKt/V &#8805; 1.2 (as per KDOQI Guidelines) prior to start of screening procedures OR no less than 3 dialysis sessions per week with a total dialysis time &#8805; 12 hours per week. 5. Willingness to commence
    1. Consenso informato ottenuto prima di svolgere qualsiasi attivita` di studio (per ``attivita` di studio`` si intendono le procedure che non rientrano nella gestione ordinaria del paziente) 2. Soggetti di sesso maschile o femminile in emodialisi cronica (&#8805; 3 mesi dallo screening) (includendo ogni tipo di emodialisi: giorno corto, notturna ecc), di eta` &#8805; 18 anni 3. Albumina sierica &lt; 40 g/L (livello ottenuto dalla media di tre misurazioni analizzate da un laboratorio centrale) 4. Trattamento emodialitico stabile (&#8805; 3 mesi) e appropriato nei tre mesi precedenti l'arruolamento, definito da non meno di tre valori Kt/V &gt; 1,2 mensili prima di iniziare le procedure di screening o non meno di 3 sessioni di dialisi a settimana con un totale di tempo di dialisi &#8805; 12 ore a settimana. 5. Disponibilita` ad iniziare una terapia insulinica laddove ritenuto necessario dallo Sperimentatore e/o da un valutatore indipendente.
    E.4Principal exclusion criteria
    1. Previous randomization in this trial. Re-screening of previous screening failures (due to inclusion criterion number 3 and/or exclusion criteria numbers 3, 5-8, 10d, 10e, 11 or 12) is allowed twice within the trial recruitment period: • The first re-screen may occur at any time after the initial screen failure date. However, all screening procedures must be repeated if the re-screening date occurs greater than seven weeks from Visit 1 of the first screen. • The second re-screen must be performed no sooner than 6 months after the V1 of the first screen. However, screening procedures must be repeated if the re-screening date occurs greater than seven weeks from Visit 1 of the first re-screen. 2. Active malignant disease (defined as less than 5 years since receiving a diagnosis of being malignancy-free) 3. Critical illness as defined by the need of respiratory or circulatory support (admitted to an intensive care unit [ICU]) 4. Known or suspected allergy to trial product(s) or related products 5. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice including abstinence, oral contraceptives, intrauterine devices, barrier (diaphragm or condom) plus spermicide, injectable or implantable contraceptives) 6. Uncontrolled treated/untreated hypertension (systolic blood pressure [pre-dialysis] > 180 mmHg or diastolic blood pressure [pre-dialysis] >110mmHg) in two of the last three predialysis blood pressure recordings taken at the preceding three consecutive dialysis sessions. 7. Patients on chronic treatment with corticosteroids in doses > 10 mg/day prednisolone (or equivalent) during the month preceding screening. 8. Patients treated with immunosuppressive agents during the month preceding screening. 9. Known GH Deficiency 10. Patients suffering from a. Active vasculitis
    1. Precedente randomizzazione in questo studio. E` eventualmente consentito ripetere lo screening per precedenti fallimenti allo screening (a causa del criterio di inclusione e e/o dei criteri di esclusione 3, 5-8, 10.d, e, 11 o 12) una volta durante il periodo di arruolamento Il primo re-screening puo` avvenire in ogni momento dopo la data iniziale di screening failure. Comunque tutte le procedure di screening devono essere ripetute se la data di rescreening e` oltre le 7 settimane dalla vista 1 della prima valutazione. Il secondo re-screening si puo` fare non prima di 6 mesi dopo la V1 della prima valutazione. Comunque tutte le procedure di screening devono essere ripetute se la data di rescreening e` oltre le 7 settimane dalla vista 1 della prima valutazione. 2. Malattia maligna in fase attiva (definita come meno di cinque anni dalla diagnosi dello stato di assenza della malattia) 3. Malattia critica definita come necessita` di ricevere assistenza respiratoria o circolatoria (con ricovero in Unita` di terapia intensiva (UTI)) 4. Allergia, nota o sospetta, ai prodotti in studio o ad altri prodotti correlati 5. Donne in eta` fertile che abbiano sviluppato una gravidanza, allattino al seno o programmino una gravidanza e non utilizzino metodi contraccettivi adeguati, (adeguate misure contraccettive come definite dalla legislazione o dalla prassi locale, quali astinenza, contraccettivi orali, dispositivi intrauterini (IUD), metodo di barriera (diaframma o preservativo) piu` spermicida, contraccettivi iniettabili o impiantabili), 6. Ipertensione non controllata, trattata o meno (pressione sistolica (predialisi) &gt; 180 mmHg o diastolica &gt;110 mmHg) in due delle ultime tre pressione predialisi registrate nelle tre precedenti sessioni continue di dialisi. 7. Pazienti in trattamento steroideo cronico a dosi &gt; 10 mg/giorno di prednisolone (o equivalente) nel mese precedente allo screeining. 8. Pazienti Trattati con agenti immunosoppressivi nel mese precedente allo screening. 9. Carenza nota di ormone della crescita 10. Pazienti affetti da: a. vasculite attiva b. grave scompenso cardiaco congestizio equivalente alla classe NYHA (New York Heart Association) IV (per una definizione delle classi NYHA vedere l'Appendice C) c. grave malattia infiammatoria sistemica ad andamento cronico, come definito da un trattamento cronico con immunosoppressivi d. grave malattia infiammatoria/infettiva sistemica acuta e. grave malattia epatica definita da livelli di ALT o AST &gt; 3 volte superiori al range della norma (e` consentito un re-test analizzato dal laboratorio centrale entro una settimana e l'ultimo campione e` ritenuto conclusivo) f. retinopatia2 diabetica non proliferativa grave o proliferativa in fase attiva. Pazienti che si sono sottoposti con successo ad un trattamento laser per la retinopatia sono eleggibili. g. incapacita` mentale, indisponibilita` o barriere linguistiche che precludano un'adeguata comprensione
    E.5 End points
    E.5.1Primary end point(s)
    Mortality o Time to all-cause death for the pooled non-diabetic/diabetic population'
    Endpoint primario • Mortalita` o tempo al decesso per i gruppi di pazienti non-diabetici/diabetici
    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. 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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.1.1Number of subjects for this age range: 0
    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.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-11-09. Yes
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 2500
    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 Decision2007-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-10-30
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