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    The EU Clinical Trials Register currently displays   38003   clinical trials with a EudraCT protocol, of which   6235   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-001991-76
    Sponsor's Protocol Code Number:20141010
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-10-30
    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 ConcernedGermany - BfArM
    A.2EudraCT number2014-001991-76
    A.3Full title of the trial
    Initial treatment of idiopathic nephrotic syndrome in children with mycophenolate mofetil vs. prednisone: A randomized, controlled, multicenter study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Initial treatment of nephrotic syndrome in children
    A.3.2Name or abbreviated title of the trial where available
    INTENT
    A.4.1Sponsor's protocol code number20141010
    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 SponsorRuprecht-Karls-University Heidelberg, Medical Faculty represented by Universitätsklinikum Heidelberg and its Commercial
    B.1.3.4CountryGermany
    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 supportBMBF
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Köln
    B.5.2Functional name of contact pointDepartment of Pediatrics
    B.5.3 Address:
    B.5.3.1Street AddressKerpenerstr. 62
    B.5.3.2Town/ cityKöln
    B.5.3.3Post code50937
    B.5.3.4CountryGermany
    B.5.4Telephone number+492214784319
    B.5.5Fax number+492214785835
    B.5.6E-mailMarcus.Benz@uk-koeln.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 CellCept
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration LTD
    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.3.4Pharmaceutical form Powder for oral suspension
    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 INNMycophenolatmofetile
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number35
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country 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.3.1Product nameprednisone
    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 INNPrednisone
    D.3.9.1CAS number 53-03-2
    D.3.9.3Other descriptive namePREDNISONE
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number40 to 60
    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
    Idiopathic nephrotic syndrome in childhood
    E.1.1.1Medical condition in easily understood language
    nephrotic Syndrome in childhood
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10029164
    E.1.2Term Nephrotic syndrome
    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 main purpose of the study is to show that MMF in the initial treatment of SSNS in children is not inferior regarding maintenance of initial remission and subsequent relapse rate compared to the standard high-dose prednisone regimen
    E.2.2Secondary objectives of the trial
    Secondary endpoints are divided into five items:
    1.Course of the disease as described by the following criteria
    a.Time from remission to first relapse
    b.Number of relapses during follow-up
    c.Mean relapse rate per patient and year
    d.Number of frequent relapsers
    e.Time from remission to intensification of immunosuppressive treatment with other drugs due to glucocorticoid-induced toxicity
    f.Rate of patients who require more intense immunosuppressive treatment
    2.Glucocorticoid-associated toxicity
    3.Mycophenolate mofetil-associated toxicity
    4.Health-related quality of life,
    5.Days missing school attendance and days of hospitalization
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: Measurement of Inosine-5'-monophosphate dehydrogenase (IMPDH) activity in pediatric patients with steroid-sensitive nephrotic syndrome under therapy with mycophenolate mofetil
    Version and date: Version 1.0, 21.07.2016
    Objective: measurement of IMPDH activity
    Titel: Messung der Inosin 5´-Monophosphat-Dehydrogenase (IMPDH) Aktivität bei pädiatrischen Patienten mit einem steroidsensiblen nephrotischen Syndrom unter Mycophenolatmofetil-Therapie
    Version und Datum: Version 1.0, 21.07.2016
    Ziele: Messung der IMPDH Aktivität. Im einzelnen: Ist das Ansprechen
    auf die Therapie mit MPA abhängig von der basalen IMPDH-Aktivität vor Therapie? Ist das Ansprechen auf die Therapie mit MPA abhängig von der maximalen IMPDH-Aktivitäts-Hemmung? Ist die Hemmung der IMPDH-Aktivität abhängig von der Konzentration der freien MPA und/ oder der Gesamt-MPA?
    E.3Principal inclusion criteria
    Subjects meeting all of the following criteria will be considered for admission to the study:
    -First episode of steroid-sensitive nephrotic syndrome (SSNS)
    -in remission induced by daily glucocorticoids
    -male and female children aged ≥ 1 year and ≤ 10 years at beginning of study (typical age range of patients with SSNS
    -Ability of the persons having care and custody of the child to understand character and individual consequences of clinical study
    -Written informed consent of the persons having care and custody of the child (must be available before enrolment in the study)
    E.4Principal exclusion criteria
    Subjects presenting with any of the following criteria will not be included in the study:

    -Secondary nephrotic syndrome
    -estimated glomerular filtration rate (eGFR) <90 ml/min x 1.73 m2 BSA
    -Ongoing treatment with systematically administered glucocorticoids or other immunosuppressive drugs at time of first episode of nephrotic syndrome.
    • Hemoglobin concentration of ≤9 g/dL
    • Leucocyte count of ≤2.500/µl
    Refusal of subject (please see also chapter 10.5)•
    Severe chronic gastrointestinal disease

    -History of hypersensitivity to mycophenolate mofetil or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of suspension of mycophenolate mofetil (CellCept suspensionīƒĸ)
    -Participation in other clinical studies or observation period of competing studies, respectively.
    E.5 End points
    E.5.1Primary end point(s)
    Occurence of treated relapse within 24 months after end of Initial treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 8, 27 month after day 1.
    E.5.2Secondary end point(s)
    Key secondary endpoint(s):
    • Course of the disease: Time from remission to first relapse; number of relapses; mean relapse rate per patient and year; incidence of frequent relapsers
    • Prednisone-associated toxicity: Cumulative prednisone dose (mg/m² BSA); body mass index (standard deviation score); striae; hypertrichosis; acne; arterial hypertension; disturbances of carbohydrate and lipid metabolism; growth failure; cataract; glaucoma; psychological disturbances
    • MMF-associated toxicity: diarrhea; blood cell count disturbances, infections
    E.5.2.1Timepoint(s) of evaluation of this end point
    27 month after day 1
    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 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 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned34
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days10
    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: 340
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 100
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 240
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state340
    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)
    routine treatment
    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 Decision2015-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-18
    P. End of Trial
    P.End of Trial StatusOngoing
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