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    Summary
    EudraCT Number:2015-000925-36
    Sponsor's Protocol Code Number:CCFZ533X2201
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-11-25
    Trial results View 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 number2015-000925-36
    A.3Full title of the trial
    A 12-month randomized, multiple dose, open-label, study evaluating safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD) and efficacy of an anti-CD40 monoclonal antibody, CFZ533, in combination with mycophenolate mofetil (MMF) and corticosteroids (CS), with and without tacrolimus (Tac), in de novo renal transplant recipients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CCFZ533X2201 PoC study in de novo renal transplantation
    A.3.2Name or abbreviated title of the trial where available
    CCFZ533X2201
    A.4.1Sponsor's protocol code numberCCFZ533X2201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02217410
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma Services AG
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressLichtstrasse 35
    B.5.3.2Town/ cityBazel
    B.5.3.3Post code4056
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+4161324 1111
    B.5.5Fax number+4161324 8001
    B.5.6E-mailclinicaltrial.enquiries@novartis.com
    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 No
    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.3.2Product code CFZ533
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCFZ533
    D.3.9.3Other descriptive nameCFZ533
    D.3.9.4EV Substance CodeSUB130512
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    acute rejection of renal transplant in de novo adult renal transplant patients
    E.1.1.1Medical condition in easily understood language
    rejection of the kidney transplant in adult patients receiving a kidney transplant
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10023438
    E.1.2Term Kidney transplant
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This is a three part study in de novo renal transplant patients
    Primary Objectives:
    Part 1: Assess the safety, tolerability, and PK of multiple IV and SC doses of CFZ533 in combination with MMF, CS, and Tac over the treatment and follow up period
    Parts 2: Assess the potential for CFZ533 to act as the primary immunosuppressant in a CNI-free regimen with MMF as assessed by tBPAR at Month 3 post-transplantation
    Part 3:
    - Assess the potential for CFZ533 to act as the primary immunosuppressant in a CNI-free regimen with MMF as assessed by achieving non-inferiority for the composite efficacy failure endpoint (tBPAR, graft loss, death, or loss to follow up) at Month 6 post-transplantation
    - Demonstrate superior renal function at Month 6 as assessed by mean eGFR using MDRD
    E.2.2Secondary objectives of the trial
    This is a three part study in de novo renal transplant patients
    Secondary Objectives
    Parts 1,2,3:
    •Quantify CD40 occupancy on B-cells (Parts 1,2,3) and changes in total sCD40 (Parts 1,2 ) and total sCD154 (Part 1) in peripheral blood
    •Evaluate CFZ533 immunogenicity
    Parts 2,3:
    •Assess the safety and tolerability and PK of CFZ533 in combination with MMF and CS up to Month 3 for Part 2, and up to Month 6-12 in Part 3, against control
    •Compare renal function in CFZ533 treatment arms to control at Month 3 for Part 2, and at Month 3, 6 and 12 for Part 3 as assessed by
    -eGFR
    -Proportion of pts with eGFR <60 mL/min/1.73m2 at Month 3 for Part 2 and at Month 3, 6 and 12 or EOS for Part 3
    -Proportion of pts with negative eGFR slope at Month 3 for Part 2, and at Month 6 and 12 or EOS by comparison to eGFR measured at Month 3 for Part 3
    Part 3:
    •Assess the rate of tBPAR at Month 6 and 12
    •Determine the concentration range of CFZ533 with the best benefit/risk profile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Main Inclusion Criteria:
    • Written informed consent must be obtained before any assessment is performed.
    • Recipients of a kidney transplant from a heartbeating deceased, living unrelated or nonhuman leukocyte antigen (HLA) identical living related donor.
    • Recipients of a kidney with a cold ischemia time (CIT) < 30 hours.
    • other protocol-defined inclusion criteria may apply
    E.4Principal exclusion criteria
    Main Exclusion Criteria:
    •Recipients of an organ from a nonheart beating donor.
    • ABO incompatible or complement dependent lymphocytotoxic (CDC) crossmatch positive transplant.
    • Subjects receiving a second kidney allograft, unless the first allograft was lost due to surgical complication.
    • Subjects at high immunological risk for rejection
    • Subjects at risk for tuberculosis (TB)
    • Subject with severe systemic infections, current or within the two weeks prior to randomization/enrollment.
    • Any additional contraindication to the use of tacrolimus or mycophenolate mofetil according to the
    national labeling information of these products (see local product label).
    • other protocol-defined exclusion criteria may apply
    E.5 End points
    E.5.1Primary end point(s)
    Parts 1: Safety, tolerability and PK of CFZ533 in combination with MMF, CS, and Tac
    Part 2: tBPAR at Month 3
    Part 3:
    - tBPAR, graft loss, or death at Month 6 post-transplant.
    - renal function at Month 6 as assessed by mean estimated GFR
    E.5.1.1Timepoint(s) of evaluation of this end point
    Parts 1,2: Month 3
    Part 3: Month 6
    E.5.2Secondary end point(s)
    • Safety and tolerability of CFZ533 in combination with MMF and CS up to Month 3 for Part 2, and up to Month 6-12 in Part 3, against control
    • PK of CFZ533 over the 12-month treatment period (Parts 2,3)
    • tBPAR at Month 6 and 12 (Part 3)
    • CD40 occupancy on B-cells (Parts 1,2,3) and changes in total sCD40 (Parts 1,2 ) and total sCD154 (Part 1) in peripheral blood
    • CFZ533 immunogenicity (Parts 1,2,3)
    • eGFR at Month 3 for Part 2, and at Month 3, 6 and 12 for Part 3
    • Concentration range of CFZ533 with the best benefit/risk profile
    E.5.2.1Timepoint(s) of evaluation of this end point
    Parts 1: Month 3
    Part 2,3: Month 3, Month 6, Month 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    Germany
    Netherlands
    United States
    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 years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    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: 276
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 306
    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 Decision2015-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-29
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