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    Summary
    EudraCT Number:2013-000226-55
    Sponsor's Protocol Code Number:STARMEN01-2013
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-06-24
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-000226-55
    A.3Full title of the trial
    European Multicenter and Open-Label Controlled Randomized Trial to evaluate the Efficacy of Sequential Treatment with Tacrolimus-Rituximab versus Steroids plus Cyclophosphamide in patientes with Primary Membranous Nephropathy
    Europese Multicenter en Open-label gecontroleerde, gerandomiseerde studie ter vergelijking van de effictiviteit van Sequentiële Therapie met Tacrolimus en Rituximab versus therapie met steroiden en cyclofosfamide in patienten met Primaire Membraneuze Nefropathie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SEQUENTIAL THERAPY WITH TACROLIMUS AND RITUXIMAB IN PRIMARY MEMBRANOUS NEPHROPATHY
    SEQUENTIELE THERAPIE MET TACROLIMUS EN RITUXIMAB IN IDIOPATHISCHE MEMBRANEUZE NEFROPATHIE
    A.3.2Name or abbreviated title of the trial where available
    STARMEN
    STARMEN
    A.4.1Sponsor's protocol code numberSTARMEN01-2013
    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 SponsorFundacion Renal Iñigo Alvarez Toledo
    B.1.3.4CountrySpain
    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 supportERA-EDTA
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAPICES SOLUCIONES, S.L.
    B.5.2Functional name of contact pointClinical Operations Department
    B.5.3 Address:
    B.5.3.1Street AddressSalamanca, 7
    B.5.3.2Town/ cityTorrejón de la Calzada (MADRID)
    B.5.3.3Post code28991
    B.5.3.4CountrySpain
    B.5.4Telephone number+34918166804103
    B.5.5Fax number+34918169172
    B.5.6E-mailjuanluis.sanz@apices.es
    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 Tacrolimus
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTACROLIMUS
    D.3.4Pharmaceutical form Concentrate and solvent for solution for infusion
    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 INNTACROLIMUS
    D.3.9.3Other descriptive nameTACROLIMUS
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,05
    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 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 MabThera
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameRituximab
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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: 3
    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 Methylprednisolone
    D.2.1.1.2Name of the Marketing Authorisation holder-
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameMethylprednisolone
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    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 INNmethylprednisolone
    D.3.9.3Other descriptive nameMETHYLPREDNISOLONE
    D.3.9.4EV Substance CodeSUB08872MIG
    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: 4
    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 Prednisolone
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Coated 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.3.9.3Other descriptive namePREDNISOLONE ACETATE
    D.3.9.4EV Substance CodeSUB04014MIG
    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: 5
    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 cyclophosphamide
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 namecyclophosphamide
    D.3.4Pharmaceutical form Capsule
    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 INNCYCLOPHOSPHAMIDE
    D.3.9.1CAS number 50-18-0
    D.3.9.4EV Substance CodeSUB06859MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    Primary membranous nephropathy
    Idiopathische membraneuze nefropathie
    E.1.1.1Medical condition in easily understood language
    MEMBRANOUS NEPHROPATHY
    membraneuze nefropathie
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The proportion of patients reaching CR defined as a reduction of proteinuria since baseline level to a value equal or lower than 0.5 g/24 h proteinuria plus stable renal function (eGFR >= 45 ml/min/1.73m2) or PR defined as a reduction of proteinuria since baseline level to a value less than 3.5 g/24 h and 50% lower than baseline proteinuria plus stable renal function (eGFR >= 45 ml/min/1.73m2) at 24 months of study treatment.
    Het percentage patienten dat een complete remissie (CR) bereikt, gedefinieerd als een afname van proteïnurie vanaf baseline tot een waarde gelijk aan of lager dan 0,3 gram/24hr met stabiele nierfunctie (eGFR ≥ 45 ml/min/1.73m2) en het percentage patiënten met een
    partiële remissie (PR) gedefinieerd als een afname van proteïnurie vanaf baseline tot een waarde kleiner dan 3,5 gram/24hr en 50% lager dan baseline proteïnurie plus stabiele nierfunctie (eGFR ≥ 45 ml/min/1.73m2). Deze uitkomsten worden op 24 maanden
    vergeleken.
    E.2.2Secondary objectives of the trial
    The proportion of patients with LR defined as a reduction of proteinuria since baseline level > 50% but to a value > 3.5g/24 h. at 12, 18 and 24 months of study treatment.
    The number of patients with an increase >= 50% of SCr from baseline at 12, 18 and 24 months (end of the follow-up).
    The time of renal survival (status free of increase >= 50% of baseline SCr) in both arms overall after the study.
    The proportion of patients with preserved renal function (estimated GFR >= 45ml/min) in both treatment arms after the treatment period.
    The proportion of patients with relapse (defines as the reappearance of proteinuria > 3.5 gr/24h and at least 50% increase over the lowest baseline value in at least three consecutive visits in those patients who previously presented a PR or CR) and the time to relapse after the treatment period.
    Serum antibodies anti-PLA2R levels before of treatment and at 12 and 24 months of study in both treatment arms.
    Het percentage patiënten met een beperkte respons gedefinieerd als een afname van proteïnurie vanaf baseline > 50% maar met een waarde groter dan 3,5 gram/24hr, op 12, 18 en 24 maanden na start behandeling.
    Het aantal patiënten met een toename van het serum kreatinine van >= 50% vanaf baseline op 12,18 en 24 maanden (end-of follow-up).
    De tijd van renale overleving (status vrij van >=50% toename van serum kreatinine) in beide studie armen gedurende de totale studie.
    Het percentage patiënten met behouden nierfunctie (eGFR ≥45 ml/min) in beide studiearmen na de behandelperiode.
    Het aantal patiënten met een recidief nefrotisch syndroom ( gedefinieerd als opnieuw optreden van proteinurie > 3,5 gram/24 hr en minstens 50% toename vaanf de laagste waarde tijdens ten minste 3 bezoeken) na eerder bereikte PR of CR en de tijd tot een recidief NS na einde van de behandeling.
    De titer van serum anti-PLA2R antistoffen voor en na behandeling in beide armen (0, 12 en 24 maanden).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients are willing and are able to read and correctly understand the patient?s information sheet and give their consent for participation in the study (by correctly signing and dating the informed consent form document, which has been previously approved by an Ethics Committee/ International Review Board), before initiating any protocol-specific selection procedure
    - Ability to understand study procedures and to comply with them for the entire length of the study.
    - Age over 18 years.
    - Biopsy-proven primary MN whitin the last two years. Patients with nephrotic syndrome relapse after remission (either spontaneous or induced by immunosupression) can be included without a new renal biopsy, provided that they meet all the other inclusion/exclusion criteria.
    - Estimated GFR >= 45 ml/min/1.73m2.
    - Nephrotic-range proteinuria (>4 g/day and remaining >50% of the baseline value) accompanied by hypoalbuminemia (<3 g/dL) during at least a six-month period before screening.
    - Treatment with an ACEI or ARB for at least 2 months before screening, with a controlled blood pressure in at least last three months (target < 140/90 mmHg).
    - Negative urine pregnancy test for female potentially fertile.
    - Patienten die bereid zijn en in staat zijn om de schriftelijke patientinformatie te lezen en te begrijpen en die hun toestemming voor deelname aan de studie kunnen geven ( door het informed consent document correct te tekenen en te dateren), voor start van de screeenings- en selectieprocedure.
    - Vermogen om studie procedures te begrijpen en zich hieraan te houden gedruende de hele studie periode
    - Leeftijd ouder dan 18 jaar.
    - Biopsie bewezen idiopathische MN gediagnosticeerd in de afgelopen 2 jaar. Patiënten met een recidief nefrotisch syndroom na eerdere remissie (zowel spontaan of geïnduceerd door immuun-suppressieve therapie) kunnen geïncludeerd worden zonder nieuwe nierbiopsie, mits zij aan alle andere in- en exclusiecriteria voldoen.
    - Geschatte GFR >= 45 ml/min/1.73m2 bij tenminste 2 metingen binnen 2 weken voor randomisatie.
    - Nephrotic-range proteïnurie (>4 g/dag en persisterend >50% van de baseline waarde) met daarbij een hypoalbuminemie (<30 g/L) gedurende minimaal 6 maanden voor screening.
    -Behandeling met een ACE-remmer of ARB gedurende minstens 2 maanden voor screening met een gereguleerde bloeddruk gedurende minstens 3 maanden (target < 140/90 mmHg).
    - Negatieve urine zwangerschapstest test voor vrouwen in de vruchtbare leeftijd.
    E.4Principal exclusion criteria
    - Diagnosis of secondary causes of membranous nephropathy: diagnosis of type 1 or 2 diabetes mellitus, malignancy (cancer), systemic infections (which include viral, malaria, B and C hepatitis, leprosy and syphilis), systemic autoimmune diseases (e.g. Systemic Lupus Erythematosus; SLE), amyloidosis, or any other acute or chronic inflammatory disease.
    - HIV infection.
    - Moderate or severe liver disease (AST and ALT > 2.5x upper range limit and total bilirrubin > 1.5 x upper range limit).
    - Patients are taking part in any other study with an investigational study and/or are receiving or have received treatment with another investigational drug or intervention (within the first month prior to the study).
    - Suspected or known hypersensitivity, allergy and/or immunogenic reaction history of either rituximab, cyclosporine, tacrolimus, corticosteroids, CYC or any of their ingredients (which include excipients) and of any other drug from the same pharmacotherapeutic group (i.e. calcineurin inhibitors, specific monoclonal antibodies or alkylating agents).
    - Previous treatment with corticosteroids or any other immunosuppressive drug in the two-year period before screening.
    - Patients who were non responders to previous immunosuppressors.
    - Women showing a positive pregnancy test or during lactation period or plans to become pregnant. Women not using contraceptive methods during the complete study.
    - Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
    - Any other medical unstable, uncontrolled, or severe condition or any other relevant laboratory test finding which, at the investigator?s own discretion, could possibly increase the associated risk of the patient?s participation in the study.
    - Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
    - Diagnose van een secundaire oorzaak voor membraneuze nefropathie: type 1 of 2 diabetes mellitus, maligniteit, systemische infecties (inclusief virale infecties, malaria, hepatitis B en C, lepra en syfilis), systemische autoimmuun ziekten (bijv Systemische Lupus Erythematosus; SLE), amyloidose, of elke andere acute of chronische inflammatoire ziekte.
    - HIV infectie.
    - Matige of ernstige leverziekte (ASAT en ALAT > 2.5x bovengrens van normaal en totaal bilirubine > 1.5 x bovegrens van normaal).
    - Patienten die deelnemen in welke andere onderzoekstudie dan ook, of die behandeling krijgen met een andere studiemedicatie of interventie, of hebben gekregen minder dan een maand voor de huidige studie.
    - Vermoede of bekende overgevoeligheid, allergie en/of immunogene reactie in de voorgeschiedenis voor ofwel rituximab, ciclosporine, tacrolimus, corticosteroiden, cyclofosfamide of één van hun ingredienten (inclusief vulstoffen) en voor enige ander medicament uit dezelfde farmacotherapeutische groep (bijv. calcineurine remmers, specifieke monoclonale antistoffen of alkylerende middelen).
    - Eerdere behandeling met corticosteroiden of enige ander immunosuppressief medicament in de 2 jaar voor screenig.
    - Patienten die gefaald hebben op eerdere immuunsuppressieve therapie (non-responders).
    - Vrouwen met een ppositieve zwangerschapstest, gedurende een borstvoedingsperiode, of met plannen om zwanger te worden. Vrouwen in de vruchtbare leeftijd die geen contraceptiva gebruiken gedurende de volledige studie
    - Onvermogen of onbereidheid om geschreven informed consent te geven.
    - Elke andere medische, instabiele, ongecontroleerde of ernstige conditie of elke andere relevante bevinding bij laboratorium onderziek, die, na afweging door de onderzoeker, mogelijk het risico voor de patient bij deelname aan de studie verhoogd.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients reaching complete remission (CR) and partial remission (PR) at 24 months of study treatment.
    Het percentage patiënten dat een complete en/of partiële remissie bereikt heeft 24 maanden na start behandeling.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months after start of treatment
    24 maanden na start behandeling
    E.5.2Secondary end point(s)
    a) The number of patients with an increase of serum creatinine ≥ 50% at the end of follow-up (renal survival).
    b) The proportion of patients with an nephrotic syndrome relapses in those patients who previously presented a PR or CR.
    c) The time to NS relapses in both arms after the treatment period.
    d) The number of patients with limited response at 12, 18 and 24 months of study treatment.
    e) The percentage of patients with preserved renal function (eGFR≥45 ml/min) after the treatment period.
    f) Serum antibodies anti-PLA2R levels before, and after treatment study in both arms (0,12, and 24 months).
    g) Status of immune cells (CD4+, and CD8+ T cells and CD19+ B cells) before and after the treatment study in both arms (0,12, and 24 months).
    h) Proportion of patients with drug-related adverse events during the study
    - To evaluate the number (percentage) of patients with preserved renal function (estimated GFR>45 ml/min/1,73m2) after the treatment period at 12, 18 and 24 months in both treatment arms.
    - To evaluate the number of patients with LR (defined as a reduction of proteinuria since baseline level > 50% but to a value > 3.5g/24 h at 12, 18 and 24 months of study treatment) in both groups.
    - To evaluate the number of patients with >= 50% increases of SCr from baseline at the end of the follow up.
    - To evaluate the number and severity of side effects in both treatment arms during the study.
    - To determine the status of serum antibodies anti-PLA2R levels before the treatment and after the treatment period at 12 and 24 months in both treatment arms.
    - To determine the status of immune cells (CD4+ and CD8 T cells and CD19+ B cells) before the treatment and after the treatment period at 12 and 24 months in both arms.
    - To identify known and potential novel clinical, laboratory and histologic predicting factors of response to treatment, relapse and renal outcomes.

    a) Het aantal patiënten met een toename van het serum kreatinine van > 50% aan het einde van de follow-up (renale overleving).
    b) Het aantal patiënten met een recidief nefrotisch syndroom na eerder bereikte PR of CR.
    c) De tijd tot een recidief NS na einde van de behandeling in beide groepen.
    d) Het aantal patiënten met een beperkte respons (gedefinieerde "limited respons") op 12, 18 en 24 maanden na start behandeling.
    e) Het percentage patiënten met behouden nierfunctie (eGFR≥45 ml/min) na de behandelperiode
    f) De titer van serum anti-PLA2R antistoffen voor en na behandeling in beide armen (0, 12 en 24 maanden).
    g) Status van immuuncellen (CD4+ en CD8+ T cellen en CD19+ B cellen) voor en na behandeling in beide armen (0, 12 en 24 maanden).
    h) Het percentage patiënten met medicatie-gerelateerde bijwerkingen in de studie
    E.5.2.1Timepoint(s) of evaluation of this end point
    0, 12, 18 and 24 months
    0, 12, 18, en 24 maanden
    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 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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    The sponsor may suspend or cancel the study in accordance with GCPs, in whole or in part, at any time for any reason. If the investigator decides to suspend or cancel the study, he/she shall promptly notify the sponsor and the Ethics Committee with a detailed written explanation. The investigator will then give back to the sponsor the required study materials.
    De sponsor/verrichter van het onderzoek kan de studie schorsen of beeindigen in lijn met de regels voor GCP, zowel gedeeltelijk als in zijn geheel, op elk moment en met elke reden. Indien de onderzoeker beslist om de studie te schorsen of te beeindigen, zal hij/zij direct de Commissie Mensgebonden Onderzoek hiervan op de hoogte stellen met een gedetaileerde schriftelijke verklaring. De onderzoeker zal dan aan de sponsor/verrichter de vereiste studie materialen teruggeven.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 125
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 175
    F.4.2.2In the whole clinical trial 175
    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)
    Plans of treatment is not different from the expected normal treatment of that condition
    De behandeling na de studie is niet anders dan volgens de huidige "standard of care ".
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation ERA.EDTA
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-04
    P. End of Trial
    P.End of Trial StatusOngoing
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