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    The EU Clinical Trials Register currently displays   36378   clinical trials with a EudraCT protocol, of which   5993   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2008-005867-33
    Sponsor's Protocol Code Number:13701
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-02-25
    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 ConcernedAustria - BASG
    A.2EudraCT number2008-005867-33
    A.3Full title of the trial
    Prospective non-randomized (pharmacoepidemiologic) cohort study (open-label, multicenter) to assess the magnitude of potential risk with the administration of Primovist/Eovist in patients with moderate to severe renal impairment for the development of nephrogenic systemic fibrosis (NSF) based on diagnostically specific clinical and histopathologic information.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Saftey of Primovist/Eovist in Renally Impaired patients
    A.3.2Name or abbreviated title of the trial where available
    Primovist/Eovist in Renally Impaired patients (the PERI study)
    A.4.1Sponsor's protocol code number13701
    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 SponsorBayer HealthCare AG
    B.1.3.4CountryGermany
    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 organisationBayer HealthCare AG
    B.5.2Functional name of contact point"EU CTR" / S102 - Room 156
    B.5.3 Address:
    B.5.3.1Street AddressBayer Schering Pharma AG, Level 2, Room 156
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone numberNANANANA
    B.5.5Fax numberNANANANA
    B.5.6E-mailclinical-trials-contact@bayer.com
    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 Primovist 0.25 mmol/ml, solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderto be filled locally
    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 in pre-filled syringe
    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 INNGadoxetate disodium
    D.3.9.1CAS number 135326-22-6
    D.3.9.2Current sponsor codeZK 139834
    D.3.9.3Other descriptive nameGd-EOB-DTPA
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/ml millimole(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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 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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with moderate (eGFR 30 – 59 mL/min/1.73 m2) to severe renal impairment (eGFR < 30 mL/min/1.73 m2) scheduled to undergo contrast-enhanced MRI with Primovist/Eovist.
    E.1.1.1Medical condition in easily understood language
    Moderate to severe renal impairment.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10038469
    E.1.2Term Renal impairment NOS
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    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 assess the magnitude of potential risk of developing NSF with the administration of Primovist/Eovist in patients with moderate to severe renal impairment for the development of NSF, based on diagnostically specific clinical and histopathological information.
    E.2.2Secondary objectives of the trial
    •to assess the magnitude of the potential risk of developing cutaneous symptoms consistent with NSF with the administration of Primovist/Eovist in patients with moderate to severe renal impairment for the development of cutaneous symptoms consistent with NSF, based on specific clinical information for patients in whom biopsy is not available
    •to evaluate the confidence of the investigator to make a diagnosis based on the Primovist/Eovist enhanced MRI
    •to determine imaging efficacy by qualitatively evaluating the parameters “lesion detection”, “lesion delineation” and “lesion characterization”.
    •to evaluate the number and characteristics of adverse events reported in association with the administration of Primovist/Eovist.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Patient must be scheduled for CE-MRI OF THE LIVER with Primovist/Eovist based on careful risk/benefit evaluation at the recommended dose in one of the approved indications
    •Patient must fulfill criteria for moderate (eGFR 30 – 59 mL/min/1.73 m2) to severe (eGFR < 30 mL/min/1.73 m2) renal impairment. Patients will initially be qualified using the simplified MDRD formula, based on a determination of serum creatinine within 6 weeks prior to the administration of Primovist/Eovist. Final patient stratification will be based on the complete MDRD formula (13) based on age, gender, ethnicity; and on serum creatinine, serum urea nitrogen, and serum albumin concentration as measured within 24h prior to Primovist/Eovist administration.
    •Patient must sign study-specific informed consent.
    E.4Principal exclusion criteria
    •GBCA-enhanced MRI (or administration of a GBCA for any other CE imaging procedure) other than Primovist/Eovist within 12 months prior to administration of Primovist/Eovist
    -Rationale for selected time window: to minimize level of confounding from prior administration of GBCA for the estimation of risk of NSF for Primovist/Eovist while at the same time avoiding the elimination of too many potential participants from the study.
    -Exposure to GBCA within 12 months prior to administration of Primovist/Eovist will be determined at the time of the initial evaluation via history (elicited from patient) and review of patient’s medical records, if available at that time. Subsequently, a more thorough analysis of the patient’s medical records will be carried out to ascertain the accuracy of the GBCA exposure information obtained at the time of the ÌNITIAL EVALUATION
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point of the study is the number of patients with moderate to severe renal impairment who develop NSF, based on diagnostically specific clinical and histopathological information, following the administration of Primovist/Eovist injection within the 2-year follow-up period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    LPLV - 31 december 2014
    E.5.2Secondary end point(s)
    • Number of patients with moderate to severe renal impairment in whom no biopsy was obtained who develop NSF based on diagnostically specific clinical information. The clinical findings related to NSF will be summarized by clinical score.
    • Confidence of the investigator to make a diagnosis based on the Primovist/Eovist enhanced MRI.
    • Number and characteristics of adverse events reported in association with the administration of Primovist/Eovist.
    • Number of patients with “Excellent / Good / Adequate / Insufficient” scores for “lesion detection”, “lesion delineation” and “lesion characterization.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 2 years follow-up
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Germany
    Italy
    Korea, Republic of
    Spain
    Thailand
    United Kingdom
    United States
    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
    End of the trial is the Last Patient Last Visit date
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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: 1000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1000
    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 2009-02-25. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 700
    F.4.2.2In the whole clinical trial 1000
    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)
    NA
    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 Decision2009-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-24
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