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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:2016-003198-17
    Sponsor's Protocol Code Number:UZB_20160728
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-09-07
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2016-003198-17
    A.3Full title of the trial
    A Prospective Interventional Pilot Study on the Use of Valproic Acid for Treatment of Idiopathic Nephrotic Syndrome
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Valproic Acid for Idiopathic Nephrotic Syndrome
    Valproaat voor de behandeling van Nefrotisch Syndroom
    A.3.2Name or abbreviated title of the trial where available
    VAIN study
    A.4.1Sponsor's protocol code numberUZB_20160728
    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 SponsorUniversitair Ziekenhuis Brussel Vrije Universiteit Brussel
    B.1.3.4CountryBelgium
    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 supportUniversitair Ziekenhuis Brussel Vrije Universiteit Brussel
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitair Ziekenhuis Brussel Vrije Universiteit Brussel
    B.5.2Functional name of contact pointDr. Peter Janssens
    B.5.3 Address:
    B.5.3.1Street AddressLaarbeeklaan 101
    B.5.3.2Town/ cityBrussel
    B.5.3.3Post code1090
    B.5.3.4CountryBelgium
    B.5.6E-mailPeter.Janssens@uzbrussel.be
    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 Depakine Chrono 500©
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Treatment of Idiopathic Nephrotic Syndrome
    E.1.1.1Medical condition in easily understood language
    Adults with biopsy proven idiopathic Minimal Change Disease (MCD) or Focal Segmental Glomerulosclerosis (FSGS) currently in remission but requiring reduction or cessation of immunosuppressive therapy.
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1) VPA (Valproic acid) on top of or in substitution of standard of care agents is effective in remission induction in patients with FSGS or MCD with proteinuria resistant to first line therapy with corticosteroids.
    2) VPA is effective in remission maintenance allowing reduction and cessation of chronic immunosuppression without relapse in patients with frequently relapsing FSGS or MCD.

    This is an exploratory pilot study with two different sub-cohorts of patients which have different endpoints.
    E.2.2Secondary objectives of the trial
    Determine the disease response by the proportion of subjects with partial remission
    Determine the extent to which standard immunosuppression can be reduced
    Evaluate the evolution of renal function estimated by MDRD-GFR
    Evaluate the tolerability of VPA in the setting of idiopathic podocytopathies


    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    18 years and older
    Able to give informed consent
    Biopsy proven idiopathic FSGS or MCD
    For remission induction (currently induction therapy):
    • Proteinuria >1g/g creatinine
    • Subjects received high dose prednisone (1mg/kg-maximum 80mg prednisone-equivalent) according to guidelines or present relative contraindications or intoler-ance to high-dose corticosteroids during induction.
    For remission maintenance (currently in remission):
    • At least one relaps
    • Requiring reduction or cessation of current maintenance immunosuppressive therapy required to maintain remission.
    Organ function:
    • Bilirubin/AST/ALT< 2 ULN
    • PLT>100.000 10*6/L
    • INR1.5 except if on anti-vitamin K treatment
    • Lipase <1.5 ULN
    • Creatinine clearance >30ml/min
    E.4Principal exclusion criteria
    Patients younger than 18 years
    Unable to give informed consent
    Contraindication for VPA*
    Secondary etiologies for FSGS or MCD**
    Multiple organ transplantation
    Currently participating in another clinical trial
    Pregnant or lactating women
    Women unwilling to take efficient contraceptive measures for the duration of the study
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in remission induction is the proportion of patients in complete remission. Complete remission is defined as a reduction of proteinuria to <300mg/g creatinine or < 0.3g/d and normal serum creatinine (or stable creatinine if baseline creatinine before disease onset is well documented) and serum albumin > 3.5g/dL.

    The primary endpoint in remission maintenance is the proportion of patients able to reduce maintenance immunosuppression to a monotherapy of 4 mg methylprednisolone or less while remaining in complete remission as defined above.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For both groups, 6 months after inclusion
    E.5.2Secondary end point(s)
    Remission induction:
    1) The proportion of subjects with partial remission defined as a reduction in proteinuria to 0.3-3.5g/d or 300-3500mg/g creatinine and a decrease of at least 50% from baseline proteinuria and stable serum creatinine (change in creatinine < 25%).
    2) The percent change in proteinuria.
    3) The proportion of patients attaining full or partial remission with 4mg methylprednisolone or less.
    4) Evolution of renal function estimated by CKD-EPI.
    Remission maintenance:
    1) The proportion of patients remaining in remission after reduction of maintenance immunosuppression to monotherapy with 4 mg of methylprednisolone or less.
    2) The percent reduction in the dosage of immunosuppression in patients who remain in remission.
    3) The proportion of patients with relapse (defined as proteinuria > 3.5g/d or >3500mg/g) after minimization or cessation of immunosuppression on VPA.
    4) Evolution of renal function estimated by CKD-EPI.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Remission induction:
    1) The proportion of subjects with partial remission at 6 months
    2) The percent change in proteinuria at 6 months
    3) The proportion of patients attaining full or partial remission with 4mg methylprednisolone or less at 6 months and 12 months
    4) Evolution of renal function at 6 and 12 months
    Remission maintenance:
    1) the proportion of patients remaining in remission for at least 6 months after reduction of maintenance immunosuppression
    2) The percent reduction in the dosage of immunosuppression in patients who remain in remission at 6 and 12 months
    3) The proportion of patients with relapse after minimization or cessation of immunosuppression on VPA at 6 and 12 months
    4) Evolution of renal function at 6 and 12 months
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 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 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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    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)
    None
    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 Decision2016-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-21
    P. End of Trial
    P.End of Trial StatusOngoing
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