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    The EU Clinical Trials Register currently displays   36111   clinical trials with a EudraCT protocol, of which   5936   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-004702-56
    Sponsor's Protocol Code Number:NN1630-1453
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-08-09
    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 ConcernedGermany - BfArM
    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
    A.4.1Sponsor's protocol code numberNN1630-1453
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovo Nordisk A/S
    B.1.3.4CountryDenmark
    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.4.2Country
    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.2.1.1.1Trade name Norditropin NordiFlex® 10 mg/1,5 ml
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.2Product code NN1630
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.7
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 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)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10066623
    E.1.2Term Chronic haemodialysis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate and establish the effect of Norditropin® (somatropin) on mortality in adult patients on chronic haemodialysis
    E.2.2Secondary objectives of the trial
    To evaluate and establish
    •The effect of growth hormone on morbidity, Health Related Quality of Life (HRQoL) and other variables in 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 (≥ 3 months prior to screening) in-centre haemodialysis
    (including all types of haemodialysis: e.g., short daily, nocturnal, etc.), age ≥ 18
    3.Serum albumin < 40 g/L (median of three measurements analysed by a central laboratory)
    4.Stable (≥ 3 months) and adequate haemodialysis treatment, as defined by no less than 3 consecutive monthly spKt/V ≥ 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 ≥ 12 hours per week.
    5.Willingness to commence insulin therapy if deemed necessary by the Investigator and/or a central assessor
    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 (IUD), barrier (diaphragm or condom) plus spermicide, injectable or implantable contraceptives)
    6. Uncontrolled treated/untreated hypertension (systolic blood pressure [pre- ialysis] > 180 mmHg or diastolic blood pressure [pre-dialysis] >110mmHg) in two of the last three pre-dialysis 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 Growth Hormone Deficiency
    10.Patients suffering from
    a. Active vasculitis
    b. Severe congestive heart failure corresponding to New York Heart Association (NYHA) class IV (see Appendix C for definition of NYHA classes)
    c. Severe chronic systemic inflammatory disease, as defined by chronic treatment with immunosuppressants.
    d. Severe acute systemic infectious/inflammatory disease
    e. Severe hepatic disease, defined as ALT or AST levels > 3 times upper normal range (one re-test analysed at the central laboratory within one week is permitted with the last sample being conclusive)
    f. Active proliferative or severe non-proliferative diabetic retinopathy. Patients who have undergone successful laser treatment for retinopathy are eligible.
    g. Mental incapacity, unwillingness or language barrier precluding adequate understanding
    11. Any condition judged by the Investigator to interfere with trial participation or evaluation of results or to be potentially hazardous to the patient, including present (last use < 2 years) illicit substance abuse.
    12. The receipt of any investigational product within 1 month prior to screening in this trial. Over the counter medications or other non-investigational products are allowed.
    13. Scheduled for renal transplantation from a living donor
    within the trial period or on an urgent list for deceased organ donor kidney transplantation.
    14. Pre-existing benign intracranial tumours. Intracranial lesions must be inactive for five years, and anti-tumour therapy complete prior to the initiation of therapy
    E.5 End points
    E.5.1Primary end point(s)
    •Mortality
    - Time to all-cause death for the pooled non-diabetic/diabetic population
    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) 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.8.3 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 concerned26
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA92
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    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.1.3Elderly (>=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 2007-08-09. 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 state150
    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 Decision2007-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-23
    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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