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    The EU Clinical Trials Register currently displays   37733   clinical trials with a EudraCT protocol, of which   6184   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-003476-39
    Sponsor's Protocol Code Number:RG_12-188
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-11-30
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-003476-39
    A.3Full title of the trial
    Short course daily prednisolone therapy at the time of upper respiratory tract infection in children with relapsing steroid sensitive nephrotic syndrome; the PREDNOS 2 study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Short course daily prednisolone therapy at the time of upper respiratory tract infection in children with relapsing steroid sensitive nephrotic syndrome; the PREDNOS 2 study.
    A.3.2Name or abbreviated title of the trial where available
    PREDNOS 2
    A.4.1Sponsor's protocol code numberRG_12-188
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN10900733
    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 SponsorThe University of Birmingham
    B.1.3.4Country
    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 supportNIHR HTA
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Birmingham
    B.5.2Functional name of contact pointElizabeth Brettell
    B.5.3 Address:
    B.5.3.1Street AddressBCTU, College of Medical and Dental Sciences
    B.5.3.2Town/ cityEdgbaston, Birmingham
    B.5.3.3Post codeB15 2TT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01214159130
    B.5.5Fax number01214159135
    B.5.6E-mailE.A.Brettell@bham.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorManchester University NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportNIHR HTA
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Birmingham
    B.5.2Functional name of contact pointElizabeth Brettell
    B.5.3 Address:
    B.5.3.1Street AddressBirmingham Clinical Trials Unit
    B.5.3.2Town/ cityEdgbaston, Birmingham
    B.5.3.3Post codeB15 2TT
    B.5.4Telephone number01214159130
    B.5.5Fax number01214159135
    B.5.6E-maile.a.brettell@bham.ac.uk
    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 No
    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 namePrednisolone
    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 INNPrednisolone
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    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
    Relapsing steroid sensitive nephrotic syndrome
    E.1.1.1Medical condition in easily understood language
    Relapsing steroid sensitive nephrotic syndrome
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether a six day course of oral prednisolone given at the time of URTI reduces the incidence of first URTI-related relapse in children with relapsing steroid sensitive nephrotic syndrome.
    E.2.2Secondary objectives of the trial
    To determine whether a six day course of oral prednisolone given at the time of URTI
    i] reduces the overall rate of URTI-related relapse of nephrotic syndrome (expressed as relapses per year).
    ii] reduces the overall rate of relapse of nephrotic syndrome (expressed as relapses per year).
    iii] reduces the cumulative dose of prednisolone received over the 12 month study period.
    iv] reduces the incidence and prevalence of adverse effects of prednisolone including behavioural abnormalities.
    v] reduces the number of subjects undergoing escalation of background immunosuppressive therapy (e.g. addition of ciclosporin, tacrolimus, cyclophosphamide etc).
    vi] increases the number of subjects undergoing reduction of background immunosuppressive therapy (e.g. cessation of ciclosporin or long term maintenance prednisolone therapy).
    vii] is more cost effective than standard course therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects aged over 1 year and less than 19 years will be eligible for inclusion if they have relapsing SSNS, defined as having experienced 2 or more relapses in the preceding 12 months. This will include the following groups:
    • Subjects on no long-term immunosuppressive therapy;
    • Subjects receiving long term maintenance prednisolone therapy at a dose of up to and including 15mg/m2 on alternate days. Note that this is the maximum dose at the time of recruitment – if children subsequently receive a higher dose e.g. after relapse, they can remain in the study;
    • Subjects receiving long term maintenance prednisolone therapy at a dose of up to and including 15mg/m2 on alternate days in conjunction with other immunosuppressive therapies, including levamisole, ciclosporin, tacrolimus, MMF, mycophenolate sodium and azathioprine;
    • Subjects receiving long-term immunosuppressive therapies, including levamisole, ciclosporin, tacrolimus, MMF, mycophenolate sodium and azathioprine without long term maintenance prednisolone therapy.
    • Subjects who have previously received a course of oral or intravenous cyclophosphamide:
    o Must have experienced two relapses in the 12 months prior to randomisation (in keeping with all other subjects)
    o Must have experienced at least one of these relapses following completion of cyclophosphamide therapy
    o Must be at least 3 months post completion of oral or intravenous cyclophosphamide therapy
    • Subjects who have previously received a single dose or course of intravenous rituximab:
    o Must have experienced two relapses in the 12 months prior to randomisation (in keeping with all other subjects)
    o Must have experienced at least one of these relapses following completion of rituximab therapy
    o Must be at least 3 months post completion of intravenous rituximab therapy
    • Parents and (where age appropriate) subject understand the definition of URTI and the need to commence study drug once this definition has been met.
    • Written informed consent obtained from the subject’s parents/guardians and written assent obtained from subject (where age appropriate). Subjects aged 16 years and above will provide their own written informed consent.
    E.4Principal exclusion criteria
    • Subjects with steroid resistant nephrotic syndrome
    • Subjects receiving, or within 3 months of completing a course of oral or intravenous cyclophosphamide
    • Subjects receiving, or within 3 months of receiving a course of rituximab
    • Subjects on daily prednisolone therapy at time of recruitment
    • Subjects on a prednisolone dose of greater than 15mg/m2 on alternate days at time of recruitment
    • Subjects with a documented history of significant non-adherence with medical therapy
    • Subjects who will be transferred from paediatric to adult services during the 12 month study period.
    • Subjects unable to take prednisolone tablets, even in crushed form.
    • Known allergy to prednisolone
    E.5 End points
    E.5.1Primary end point(s)
    First URTI-related relapse of nephrotic syndrome during the 12 month follow-up period. Relapse is defined as Albustix positive proteinuria (+++ or greater) for 3 consecutive days or the presence of generalised oedema plus 3+ proteinuria. URTI-related relapse is defined as a relapse occurring within 14 days of the development of an URTI. First URTI-related relapse refers to the first URTI-related relapse which occurs within the 12 month study follow up period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients will be follow-up at baseline, 3, 6, 9, and 12 months and details of any relapses that have occured will be documented at these time points.
    E.5.2Secondary end point(s)
    i] Relapse rate (per year).
    ii] Cumulative dose of prednisolone (mg/kg).
    iii] Incidence of serious adverse events.
    iv] Incidence of adverse events.
    v] Incidence of behavioural change (as assessed by the Achenbach child behaviour checklist).
    vi] Incidence of escalation of immunosuppressive therapy.
    vii] Incidence of reduction of immunosuppressive therapy.
    viii] Cost per relapse of proteinuria.
    ix] Cost per QALY gained.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients will be follow-up at baseline, 3, 6, 9, and 12 months and details relating to any of the secondary end points be documented at these time points.
    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 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.8.2.4Number 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 concerned113
    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 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
    6 months after LVLS to allow time for final data analysis and report writing.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 280
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 50
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 150
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 80
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state360
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 360
    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)
    Were this study to show that a short course of daily prednisolone at the time of URTI effectively and safely reduces the relapse rate, this would rapidly and significantly alter practice in the UK and in other developed nations. There are already a small number of centres who routinely increase prednisolone doses in certain patients at the time of URTI, but the majority of centres do not because of a lack of sound evidence upon which to base such practice.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-04
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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