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    Summary
    EudraCT Number:2010-022313-25
    Sponsor's Protocol Code Number:CL-503012
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-02-24
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2010-022313-25
    A.3Full title of the trial
    International Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Efficacy and Safety of KIACTA™ in Preventing Renal Function Decline in Patients With AA Amyloidosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 Study comparing KIACTA™ with Placebo in the Prevention of Renal Function Decline in Patients With AA Amyloidosis
    A.4.1Sponsor's protocol code numberCL-503012
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01215747
    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 SponsorC.T. Development Switzerland SARL
    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 supportCTD Switzerland SARL
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD
    B.5.2Functional name of contact pointMonika Deme, AD Project Management
    B.5.3 Address:
    B.5.3.1Street AddressBornweg 12c
    B.5.3.2Town/ city6721 AH Bennekom
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31 630037735
    B.5.5Fax number+31 318658800
    B.5.6E-mailMonika.Deme@ppdi.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/01/051
    D.3 Description of the IMP
    D.3.1Product nameKIACTA
    D.3.2Product code NC-503
    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.3.9.2Current sponsor codeKIACTA
    D.3.9.3Other descriptive nameNC-503
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Renal Function Decline in Patients With AA Amyloidosis
    E.1.1.1Medical condition in easily understood language
    Kidney disease caused by abnormal protein called amyloids that build up in the kidneys which stops them working properly.
    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 17.1
    E.1.2Level LLT
    E.1.2Classification code 10002024
    E.1.2Term Amyloidosis NOS
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this double-blind, randomized, placebo-controlled, Phase 3 study is to assess the efficacy and safety of treatment with Kiacta in adult patients with AA amyloidosis. Efficacy will be assessed by the time from Baseline to the primary endpoint. This primary efficacy endpoint will be the time from Baseline to the earliest of a persistent decrease in creatinine clearance (CrCl) of 40% or more, a persistent increase in serum creatinine (SCr) of 80% or more, or progression to end-stage renal disease (ESRD). Safety will be assessed by the incidence of nonserious adverse events (AEs) and serious AEs (SAEs). Neither progression to ESRD nor a clinically significant change in CrCl or SCr will be considered an AE or SAE.
    E.2.2Secondary objectives of the trial
    The secondary objective will be to assess the effect of treatment with Kiacta on the slope of CrCl over time.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) Patients must be at least 18 years of age and no more than 80 years of age.

    b) Patients are males or nonpregnant, nonlactating females.
    Women must be of nonchildbearing potential (ie, more than 1 year postmenopausal or use effective contraception for at least 2 months prior to the baseline visit and through 30 days after the last dose of study medication as follows:
    i. Oral contraception with an additional barrier method (since the investigational product may impair effectiveness of oral contraception)
    ii. Double-barrier method (diaphragm with spermicidal gel or condom with contraceptive foam)
    iii. Transdermal or long-acting injected contraceptive (eg, depot medroxyprogesterone acetate [Depo-Provera®])
    iv. Intrauterine device or implantable contraceptive
    v. Partner who is surgically sterile (vasectomy)
    vi. Total abstinence.
    - A woman of childbearing potential must have a negative serum pregnancy test at the first screening visit. Urine pregnancy tests will also be performed at every subsequent visit. Should a patient become pregnant during the study, study medication will be discontinued and the patient will be withdrawn from the study and followed-up by research personnel until delivery. Pregnant women will be contacted by telephone every 3 months until delivery.
    - Male patients with partners of childbearing potential must be surgically sterile or use a contraceptive method as previously described.

    c) Patients must have a confirmed diagnosis of AA amyloidosis
    demonstrated by positive biopsy using Congo red staining and
    immunohistochemistry or immunoelectron microscopy during the
    screening period. Mass spectroscopy may be used at expert centers for the identification of the protein present IF Congo red staining is positive but immunochemistry/immunoelectron microscopy is unrevealing. The mass spectroscopy method will be used upon approval of the Sponsor on a case by case basis. The ELISA assay using monoclonal antihuman
    serum amyloid A antibodies as described by Hazenberg et al (Hazenberg
    1999) will also be allowed in sites that can demonstrate proficiency in its
    use. Tissue from previous biopsy or written pathology report confirmation of a previous biopsy can be used for confirmation of
    diagnosis provided Congo red staining and immunohistochemistry
    immunoelectron microscopy, mass spectroscopy, or the Hazenberg
    method were used as methods of confirmation.

    d) Patients must have persistent proteinuria defined as urinary protein excretion ≥1 g/24 h at 2 distinct 24-hour urine collections at least 1 week apart during the screening period.

    e) Patients must have CrCl ≥25 mL/min/1.73 m² at 2 distinct 24-hour urine collections at least 1 week apart during the screening period.

    f) Patients must have the ability and willingness to provide informed consent and to comply with all study procedures.
    E.4Principal exclusion criteria
    a) Evidence or suspicion of chronic kidney disease secondary to a disease process other than renal AA amyloidosis (eg, diabetes, long-standing uncontrolled hypertension, polycystic kidney disease, recurring polynephritis, or systemic lupus erythematosus).

    b) History of kidney transplantation.

    c) Evidence or suspicion of a cause of potentially reversible acute renal failure, such as uncontrolled hypertension, urinary tract infection, or drug nephrotoxicity within 3 months prior to the baseline visit.

    d) Presence of concomitant diseases or concomitant medication that could interfere with the interpretation of study results or compromise patient safety. To be reconfirmed at the baseline visit.

    e) Presence of conditions that could reduce life expectancy to less than 2 years. To be reconfirmed at the baseline visit.

    f) Presence of type 1 or type 2 diabetes mellitus.

    g) Presence of significant hepatic enzyme elevation or cirrhosis. Significant hepatic enzyme elevation defined by any of the following:
    • Aspartate aminotransferase >5 times the upper limit of normal (ULN)
    • Alanine aminotransferase >5 times the ULN
    • Alkaline phosphatase >5 times the ULN
    • Total bilirubin >50% above the ULN.

    h) Presence of unstable angina, myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty within 6 months prior to the baseline visit.

    i) Presence of, or history of, stroke or transient ischemic attack within 6 months prior to the baseline visit.

    j) Presence of New York Heart Association class III or IV heart failure (Section 13.1).

    k) Use of any investigational drug within 30 days prior to the first screening visit. To be reconfirmed at the baseline visit.

    l) Active alcohol and/or drug abuse.

    m) Initiation of, or any changes in, angiotensin converting enzyme inhibitor, angiotensin II receptor antagonist therapy, or renin inhibitor within 3 months prior to the baseline visit.

    n) Initiation of, or any changes in, cytotoxic agents, anti-tumor necrosis factor agents, anti-interleukin-1 or anti-interleukin-6 agents, or colchicine therapy within 3 months prior to the baseline visit.

    o) Previous use of Kiacta.

    p) History of malignancy within 5 years prior to study entry, except for cervical carcinoma in situ, nonmelanomatous carcinoma of the skin, or ductal carcinoma in situ of the breast that has been surgically cured.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the time from Baseline to the earliest of a persistent decrease in CrCl of 40% or more, a persistent increase in SCr of 80% or more, or progression to ESRD.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please see E.5.1
    E.5.2Secondary end point(s)
    The secondary efficacy endpoint will be the rate of change (slope) in CrCl over time.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please see E.5.2
    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 Yes
    E.6.13.1Other scope of the trial description
    Development of a diagnostic test for AA amyloidosis and a biomarker for
    assessment of Kiacta efficacy in a subset of patients.
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    Argentina
    Armenia
    Belgium
    Brazil
    Bulgaria
    Chile
    China
    Czech Republic
    Egypt
    Estonia
    Finland
    France
    Georgia
    Germany
    India
    Israel
    Italy
    Japan
    Latvia
    Lithuania
    Mexico
    Netherlands
    Peru
    Poland
    Portugal
    Russian Federation
    Spain
    Sweden
    Tunisia
    Turkey
    Ukraine
    United Kingdom
    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
    This is an event driven clinical trial. When the pre-defined adjudicated total events are reached, the study will not continue.
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 190
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 119
    F.4.2.2In the whole clinical trial 280
    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)
    Standard of care
    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 Decision2011-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-01-20
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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