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    Summary
    EudraCT Number:2018-002476-40
    Sponsor's Protocol Code Number:17-APN-01
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-08-14
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-002476-40
    A.3Full title of the trial
    Personalized Medicine for Membranous Nephropathy
    PMMN
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Personalized Medicine for Membranous Nephropathy
    PMMN
    A.3.2Name or abbreviated title of the trial where available
    PMMN
    A.4.1Sponsor's protocol code number17-APN-01
    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 SponsorCHU de Nice
    B.1.3.4CountryFrance
    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 supportCHU de Nice
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Nice
    B.5.2Functional name of contact pointDRCI
    B.5.3 Address:
    B.5.3.1Street Address4 avenue Reine Victoria
    B.5.3.2Town/ cityNice
    B.5.3.3Post code06003
    B.5.3.4CountryFrance
    B.5.4Telephone number04 92 03 40 11
    B.5.6E-maildrc@chu-nice.fr
    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 TRUXIMA
    D.2.1.1.2Name of the Marketing Authorisation holderCelltrion Healthcare Hungary Kft
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameTRUXIMAB
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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
    Idiopathic Membranous Nephropathy
    E.1.1.1Medical condition in easily understood language
    Idiopathic Membranous Nephropathy
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027170
    E.1.2Term Membranous nephropathy
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of a personalized treatment of nephrotic iMN driven by anti-PLA2R1 antibody epitope profile at month 0 and month 6 with the GEMRITUX therapeutic protocol to induce clinical remission of the nephrotic syndrome at month-12.
    E.2.2Secondary objectives of the trial
    To compare between a personalized treatment of iMN driven by anti-PLA2R1 antibody epitope profiles and the GEMRITUX therapeutic protocol:
    -Complete clinical and immunological remissions at M6, M12, M18, M24
    -Partial clinical remission at M6, M12, M18, M24
    -Proteinuria and albuminuria at M6, M12, M18, M24
    -Changes in proteinuria and albuminuria from baseline at M6, M12, M18, M24
    -Serum creatinine and estimated glomerular filtration rate (eGFR) at M6, M12, M18
    -Changes in serum creatinine and eGFR from baseline at M6, M12 and M18
    -PLA2R1-Ab titers at M6, M12 and M18
    -Severe infections serious adverse
    And to compare between responders versus non responders at month-12 and between relapsers versus non relapsers:
    -Lymphocyte counts: B cells (CD19, transitional, mature and memory) and T cells (CD3, CD4, CD8 and TReg) at J0, M3, M6, M12 post-rituximab infusion
    -Serum level of IL-35 at J0, M3, M6, M12 post-rituximab infusion
    -Residual serum rituximab levels at M3
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18 years or more
    - Anti-PLA2R1 activity detected by ELISA or Euroimmune IFA
    - Nephrotic syndrome defined by proteinuria > 3.5 g/24h (or UPCR > 3.5 g/g) and serum albumin < 30 g/L at diagnosis
    - eGFR (CKD-EPI) > 30 ml/min/1,73 m2 at diagnosis
    - Symptomatic treatment according to KDIGO guidelines: maximal tolerated dose of NIAT (angiotensin-converting enzyme inhibitor and/or angiotensin 2 receptor blockers, diuretics and statins)
    - Medical insurance
    - Signed informed consent
    - Having understood and accepted the need for long-term medical follow-up
    - Woman of child-bearing age must be using an effective method of contraception
    E.4Principal exclusion criteria
    - Secondary MN: MN related to cancer, infectious, systemic lupus erythematosis, drug
    - Anti-PLA2R1 antibodies not confirmed by central analysis (in this case the patient will be replaced)
    - Pregnancy or breastfeeding
    - Immunosuppressive treatment in the 3 last months
    - Cancer under treatment
    - Patient with complicated nephrotic syndrome that would require early immunosuppressive treatment (thrombosis, acute renal failure…)
    - Patients with active, severe infections or active hepatitis B
    - Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients
    - Patients in a severely immunocompromised state
    - Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease
    - Patients unable to give an informed consent
    E.5 End points
    E.5.1Primary end point(s)
    Clinical remission at month-12 (KDIGO definition):
    - complete: UPCR <0.3 g/g in spot morning urine samples and serum albumin > 35 g/L and eGFR > 60 ml/min/1.73 m2
    - partial: UPCR < 3.5 g/g with a decrease greater than 50% from baseline and serum albumin > 30 g/L and increase of serum creatinine lower than 20%
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 12 months of treatment
    E.5.2Secondary end point(s)
    1. Complete clinical remission as defined above
    2. Partial clinical remission as defined above
    3. Immunological remission: full PLA2R1 depletion measured by ELISA (titer<14RU/ml)
    4. Proteinuria and albuminuria are measured on urine sample (proteinuria-to-creatinine ratio or albuminuria-to-creatinine ratio g/g) or collected during one day (g per day)
    5. Change in proteinuria are measured in percentage change in proteinuria from baseline to M6, M12, M18, M24
    6. Serum creatinine is measured in blood sample in μmol/l and eGFR using the CKD-EPI formula.
    7. Change in serum creatinine and eGFR are measured in percentage change from baseline to M6, M12, M18, M24
    8. PLA2R1-Ab titer are measured by ELISA in RU/ml
    9. Severe infections are defined as infections that led to hospitalization during study follow-up
    10. Remission will be defined as already stated. Patients from both groups will be analysed jointly. The following risk factors will be studied in this analysis:
    -Lymphocyte counts: B cells (CD19, transitional, mature and memory) and T cells (CD3, CD4, CD8 and TReg) measured in blood sample at J0, M3, M6, post-rituximab infusion
    - Serum level of IL-35 (pg/ml) measured in blood sample at J0, M3, M6, post-rituximab infusion using ELISA
    - Residual serum rituximab levels (μg/ml) measured in blood sample at M3 post-rituximab infusion using ELISA
    - Neutralizing anti-rituximab antibodies (ng/ml) measured in blood sample at M3 and M6 post-rituximab infusion
    11. Responders are patients entered in partial or complete remission at M12. Relapse is defined by an increasinged proteinuria > 3.5 g/g after remission at M12. Patients from both groups will be analysed jointly. The risk factors studied will be the same as above measured at J0, M3, M6 and M12 post-rituximab infusion.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 12 months of treatment
    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 Yes
    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 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) No
    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 concerned19
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA19
    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
    None
    Non
    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 months
    E.8.9.1In the Member State concerned days
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state64
    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)
    usual follow up
    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 Decision2018-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-07
    P. End of Trial
    P.End of Trial StatusOngoing
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