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    Summary
    EudraCT Number:2014-001372-66
    Sponsor's Protocol Code Number:TACmono-100
    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:2014-07-08
    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 number2014-001372-66
    A.3Full title of the trial
    Tacrolimus monotherapy in immunologically low-risk kidney transplant recipients: a pilot randomized-controlled study.
    Tacrolimus monotherapie bij niertransplantatie patiënten met een immunologisch laag risico: een gerandomiseerde, gecontroleerde pilot studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tacrolimus monotherapy for low risk kidney transplant recipients.
    Tacrolimus monotherapie bij laag-risico niertransplantatie patiënten.
    A.3.2Name or abbreviated title of the trial where available
    Tacrolimus monotherapy.
    Tacrolimus monotherapie.
    A.4.1Sponsor's protocol code numberTACmono-100
    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 SponsorErasmus Medical Center
    B.1.3.4CountryNetherlands
    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 supportErasmus medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus Medical Center
    B.5.2Functional name of contact pointA. (Annelies) E. de Weerd
    B.5.3 Address:
    B.5.3.1Street Addresspostbus 2040
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3000 CA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310642135889
    B.5.6E-maila.deweerd@erasmusmc.nl
    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 Advagraf
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe BV
    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 nameAdvagraf
    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.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 CellCept
    D.2.1.1.2Name of the Marketing Authorisation holderRoche
    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 nameCellCept
    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
    kidney transplantation
    niertransplantatie
    E.1.1.1Medical condition in easily understood language
    kidney transplantation
    niertransplantatie
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    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
    Feasibility objectives:
    1. Methodology: Outcome in the control group: what is the BPAR-rate in the control group?
    2. Process: Consent rates. How many patients can be included, what is the rate of consent, determining centre willingness and capacity?
    3. Scientific (biological plausibility):
    The primary objective of the pilot study is to estimate the treatment effect using surrogate endpoints with the following immunological parameters:
    I. Detection of total alloreactive T-cell compartment by CD137+ T staining.
    II. Leucocyte subsets.
    III. In vivo assessment of general immune responses:
    - Vaccination responses: Tetanus, pneumococcus, influenza.
    IV. The incidence of infection as measured by:
    a. detection of polyoma BK viral load in serum.
    b. detection of CMV viral load in serum.
    c. hospital admission for infection-related problems.
    d. antibiotic prescriptions (treatment episode defined as 5 or more consecutive days of antibiotic treatment).
    E.2.2Secondary objectives of the trial
    1. BPAR rate 15 months after kidney transplantation.
    2. Assessment of de novo (complement-fixating) alloantibody formation as detected by Luminex.
    3. Kidney allograft function (eGFR with CKD-EPI formula and proteinuria expressed in urine protein/creatinine ratio).
    4. Detection of donor-specific CD137+ T cells.
    5. Blood pressure levels and number of antihypertensive drugs after discontinuation of MMF as compared to continuation with dual TAC/MMF therapy.
    6. Gastrointestinal symptom score and quality of life outcomes.

    Criteria for success of pilot study:
    1. A total of 120 patients is recruited within four years.
    2. Consent is given in 70% of eligible patients.
    3. The descriptive outcomes in general immune responses provide for a biological plausible benefit of TACmono over dual therapy.
    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: Identification of early diagnostic biomarkers of kidney transplant rejection in peripheral blood.
    date; may 2014, version 1.
    Key Objectives:
    1. To determine the subset composition, activation status and cytokine production capacity of circulating monocytes in relation to other types of leukocytes in patients with rejection vs. stable controls.
    2. To establish microRNA profiles of CD14++ monocytes in patients with rejection vs. stable controls.
    3. To establish the plasma profiles comprising of circulating microRNAs in patients with rejection vs. stable controls.
    4. To identify diagnostic and predictive biomarkers of rejection by correlating the obtained findings (key objective 1 to 3) to clinical parameters such as diagnosis, prognosis, response to treatment and transplant outcome.
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    - Adult patients receiving a deceased or living kidney transplant in the Erasmus Medical Center Rotterdam, The Netherlands and:
    - Historical PRA <5 and
    - HLA MM <4.
    Re-transplantation are allowed when meeting the before mentioned criteria.
    Patients have to give written informed consent to participate in the study.
    Before randomization at 6 months, renal function should be stable with eGFR (CKD-EPI formula) >30 in mL/min with proteinuria ≤0.5 gram per 10 mmol creatinin in spot urine.
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    - HLA identical living-related transplant recipients.
    - Patients with an indication to continue MMF or other immunosuppressive drugs, e.g. vasculitis, SLE etc. (according to judgement of treating physician).
    - Recipient of an ABO-incompatible allograft or with a positive crossmatch (complement-dependent cytotoxicity or flow cytometry).
    - Biopsy proven rejection three months and later after transplantation.
    - Recipient of multiple organ transplants.
    - Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating or who are unwilling to use effective means of contraception.
    - T-cell depleting therapy (anti-thymocyte globulin and alemtuzumab) after transplantation.
    E.5 End points
    E.5.1Primary end point(s)
    This pilot study is an exploratory, randomized-controlled trial. The primary endpoint of this study is a number of immunological measurements:
    - general immune responses as measured with alloreactive CD137+ T cells
    - leucocyte subsets
    - vaccination responses
    - polyoma BK viral load in serum
    - CMV viral load in serum
    - hospital admission for infection-related problems
    - antibiotic prescriptions.

    The feasibility outcomes of the pilot study will be:
    - estimation of the risk on BPAR in the control group
    - consent rate.
    - biological plausibility (see main endpoint).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Follow-up will be 15 months after transplantation.
    E.5.2Secondary end point(s)
    Secondary study parameters/endpoints
    The secondary study parameters will be:
    - BPAR rate 15 months after kidney transplantation
    - presence of complement-fixating alloantibodies.
    - renal allograft function (eGFR with MDRD formula and proteinuria expressed in urine protein/creatinine ratio).
    - number of donor-specific CD137+ T cells
    - blood pressure levels and number of antihypertensive drugs after discontinuation of MMF versus controls
    - gastrointestinal symptom score and adherence.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Follow-up will be 15 months after transplantation.
    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 No
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    This is a minimization study: dual therapy is compared to monotherapy in a non-blinded fashion.
    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 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
    The end of the trial will be 15 months after kidney transplantation.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state120
    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)
    After the trial the participants can continue their current immunosuppressive regimen:
    the control arm will continue standard therapy with Advagraf and Cellcept. The intervention arm can procede with Advagraf if no rjection episodes have occurred.
    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 Decision2014-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-16
    P. End of Trial
    P.End of Trial StatusOngoing
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