Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2007-000229-23
    Sponsor's Protocol Code Number:DGD 44-044
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-12-14
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2007-000229-23
    A.3Full title of the trial
    RENAL SAFETY EVALUATION AFTER DOTAREM-ENHANCED MRI COMPARED WITH NON-ENHANCED MRI IN PATIENTS AT HIGH RISK OF DEVELOPING CONTRAST MEDIUM INDUCED NEPHROPATHY.
    A.3.2Name or abbreviated title of the trial where available
    RESCUE
    A.4.1Sponsor's protocol code numberDGD 44-044
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Numbernot applicable
    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 SponsorGUERBET
    B.1.3.4CountryFrance
    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 DOTAREM 0.5 mmol/ml
    D.2.1.1.2Name of the Marketing Authorisation holderCODALI
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameDOTAREM 0.5mmol/m, solution for injection
    D.3.2Product code Not applicable
    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 IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGadoteric Acid (corresponding to DOTA+gadolinium oxide)
    D.3.9.3Other descriptive name1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetic acid, Gadolinium complex
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/ml millimole(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients suffering from renal insufficiency and scheduled for contrast enhanced or unenhanced-MRI
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 10.0
    E.1.2Level LLT
    E.1.2Classification code 10038474
    E.1.2Term <Manually entered code. Term in E.1.1>
    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 in at risk patients (patients with at least moderate renal insufficiency) the frequency of contrast-induced nephropathy after Dotarem-enhanced MRI, in comparison with the frequency of nephropathy after unenhanced MRI and to observe an equivalence between both procedures regarding these frequencies.
    E.2.2Secondary objectives of the trial
    -To confirm the clinical and biological safety of DOTAREM® by assessing vital signs, laboratory parameters and adverse events through a 72±24 hours post treatment (DOTAREM®) or post procedure follow-up period.
    -To assess the serum creatinine level fluctuation in term of mean difference between baseline and 72 ±24 hours after examination.
    -To evaluate the estimated Glomerular Filtration Rate fluctuation in term of percentage and mean difference between baseline and 72 ±24 hours after examination. Estimated GFR will be assessed using the MDRD study equation.
    -If possible, to assess the potential influence of hydration protocol and/or prophylactic treatment on the renal function
    In case of rise in Serum creatinine level at 72±24 hours of at least 25% or 0.5mg/dl (44.2µmol/l), to observe the percentage of patients returned at baseline level 14 days after the imaging procedure.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ·Male or female, aged ≥ 18 years;
    Female of childbearing potential must have effective contraception (contraceptive pill or Intra-Uterine Device), or be surgically sterilized, or post-menopausal (minimum 12 months of amenorrhea) or must have a documented negative urine or blood pregnancy test at screening;
    ·Patient presenting with a known stable stage III to stage IV renal insufficiency according to the K/DOQI definition, i.e., 15 < estimated GFR < 60 ml/min/1.73m² according to MDRD formula; stability will be demonstrated with 2 consecutive values (within 15% of each other): a previous value obtained at least one week in advance (not more than 6 months in advance) and the most recent one obtained prior to the study procedure, on the same day or on the day before;
    ·Patient scheduled to undergo a contrast enhanced MRI or unenhanced MRI examination to specify a diagnosis;
    .Patient receiving angiotensin-converting enzyme inhibitors, angiotensine II receptor blockers ("sartans"), diuretics and fibrates, must be receiving these drug(s) at stable dosage(s) for at least 2 weeks; in addition the dosage(s) should not be modified for the whole study duration (i.e., until 72 hours +/-24 hrs or 14 days after the imaging procedure);
    ·Patient able to understand and having provided written informed consent to participate in the trial;
    .Patient for whom blood samples can be obtained on the day of the imaging procedure or on the day before and 72 hours (+ or - 24h) after the examination.
    E.4Principal exclusion criteria
    ·Patient with a contraindication to MRI (e.g., pacemaker, aneurysm clip, severe claustrophobia, metallic joint replacement or others according to the imaging laboratory's standard practice);
    ·Patient who has a diagnosis of a hemodynamic instability (cardiogenic shock – persistent systolic pressure < 90 requiring inotropic support) or acute myocardial infraction within 15 days prior the inclusion;
    ·Patient who needs hemodialysis;
    ·Patient with known allergy to gadolinium chelates (only applicable for patient undergoing Dotarem-enhanced MRI);
    Patients receiving anticalcineurine drugs, such as ciclosporine, unless the patient has been having a stable (variation ≤15%) creatinine level for at least 6 months, as demonstrated with available creatinine values, and has been receiving the drug at stable dosage for at least 6 months; this dosage should not be modified for the whole study duration (i.e., until 72 hours +/-24 hrs or 14 days after the imaging procedure);
    ·Patient receiving any other medications known to be nephrotoxic or to cause increases in serum creatinine level (e.g., selective inhibitors of cyclo-oxygenase 2, anti-vascular Endothelium Growth Factors, vancomycine, aciclovir, aminoglycosides, amphotericin B, polymixin, platinium complexes, non-steroidal anti-inflammatory treatment except acetyl salicylic acid, etc.) within 2 weeks before first blood sample and for the whole study duration (i.e., until 72 hours +/-24 hrs or 14 days after the imaging procedure);
    ·Patients planned to either undergo surgery or receive chemotherapy within 72 hours post-procedure (i.e: before the blood test 72 hours post-procedure);
    ·Patient having had an imaging procedure (MRI or CT imaging, with contrast medium or not ) within 7 days of entering this protocol;
    ·Patient with a planned imaging procedure (MRI or CT imaging, with contrast medium or not ) within 72 hours post-procedure;
    ·Patient with newly discovered unstable diabetes (i.e. <1month, glycaemia >= 2.5g);
    E.5 End points
    E.5.1Primary end point(s)
    The evaluation of the renal tolerance after both procedures (MRI and DOTAREM®-MRI) will be done by assessing the serum creatinine levels from blood sampling taken within 24 hours before the imaging procedure and at 72 ±24 hours after the procedure.

    This study will calculate in the two groups the percentage of patients presenting with a significant creatinine level increase according to the approach described hereafter.

    Significant creatinine level increase (Nephrotoxicity) will be defined as a rise in serum creatinine level at 72±24 hours of at least 25% or 0.5mg/dl (=44.2µmol/l) compared to baseline.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    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 Yes
    E.8.1.7.1Other trial design description
    comparative descriptive
    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
    Comparator will be an examination without contrast media injection(unenhanced-MRI)
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Last visit of the last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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.1.3Elderly (>=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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients with renal insufficiency.
    F.4 Planned number of subjects to be included
    F.4.1In the member state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 134
    F.4.2.2In the whole clinical trial 134
    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)
    Plans for treatment or care after a subject has ended his/her participation in the trial is not different from the expected normal treatment of that condition.
    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 Decision2008-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-05-09
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 05 22:46:40 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA