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    Summary
    EudraCT Number:2009-013074-41
    Sponsor's Protocol Code Number:CRAD001ANO02
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-08-27
    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 ConcernedSweden - MPA
    A.2EudraCT number2009-013074-41
    A.3Full title of the trial
    A controlled randomized open-label multicentre study evaluating if early initiation of everolimus (Certican®)and early elimination of cyclosporine (Sandimmun Neoral®) in de novo heart transplant recipients can improve long-term renal function and slow down the progression of chronic allograft vasculopathy.
    A.3.2Name or abbreviated title of the trial where available
    Schedule
    A.4.1Sponsor's protocol code numberCRAD001ANO02
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Norge AS
    B.1.3.4CountryNorway
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Certican
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Sverige AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameCertican
    D.3.2Product code RAD001
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 159351-69-6
    D.3.9.3Other descriptive nameEVEROLIMUS
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Heart transplantation
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10019314
    E.1.2Term Heart transplant
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    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 between treatment regimes by assessing the difference in renal function evaluated by measured glomerular function rate (mGFR) 12 months after heart transplantation (HTX).
    E.2.2Secondary objectives of the trial
    To compare the efficacy between treatment regimens by assessing the difference in
    -Progression of chronic allograft vasculopathy (CAV) assessed by intravascular ultrasound (IVUS) examination
    -Renal function; change of GFR from visit 5 (week 7-11) to Month 12
    -Renal function; cGFR (MDRD formula) at each follow-up visit
    -Number of rejections
    -Occurrence of treatment failures up to or at 12 months
    -Development and magnitude of proteinuria
    -Lipid profile at 12 months
    -Quality of Life assessed by SF-36, EQ 5D and Becks
    -Hemodynamic variables
    -Left ventricular function
    -Optional: Working capacity (Peak oxygen uptake at week 7 and month 12)
    -Metabolic parameters
    -Inflammatory variables
    -Safety and tolerability
    -Optional: Measurements of microvascular circulation in connection to the IVUS examinations
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be fulfilled at the time of transplantation and before entering period 1 of the study
    - Male or female cardiac recipients 18-70 years of age undergoing primary heart transplantation. The graft must be functional at the time of randomization.
    - Patient willing and capable of giving written informed consent for study participation and anticipated to be able to participate in the study for 12 months
    - Patients received induction therapy with ATG (Thymoglobulin)

    At time of entering period 2:
    - Patients completed period 1 on the maintained immunosuppressive regimen they were randomized to within the target doses and levels specified for each group.
    E.4Principal exclusion criteria
    To be fulfilled at the time of transplantation and before entering period 1 of the study
    1. Recipient of multi-organ transplants or previously transplanted organs
    2. Patients with donor greater than 70 years
    3. Donor heart cold ischemic time > 6 hours.
    4. Patients who are recipients of ABO incompatible transplants
    5. Patients with platelet count < 50,000/mm3 at the evaluation before
    6. Patient who have received an unlicensed drug or therapy within one month prior to study entry or if such therapy is to be instituted post-transplantation
    7. Patient with a known hypersensitivity to cyclosporine
    8. Patient with a current severe systemic infection
    9. Patient unable to participate in the study for the full 12-month period
    10. Presence of severe hypercholesterolemia (≥ 350 mg/dL; ≥ 9 mmol/L) or hypertriglyceridemia (≥ 750 mg/dL; ≥ 8.5 mmol/L)
    11. Patients with any past (within the past 5 years) or present malignancy (other than excised basal cell carcinoma)
    12. Females capable of becoming pregnant must have a negative pregnancy test prior to randomization and are required to practice a medically approved method of birth control for the duration of the study and a period of 8 weeks following discontinuation of study medication, even where there has been a history of infertility.
    13. Patients with HIV, hepatitis B or C

    At time of entering period 2:
    1. Graft loss
    2.Patients with ongoing treatment for rejection
    3. Patients that have experienced a biopsy proven ISHLT grade 3R rejection or two or more grade 2R rejections during period 1
    4. Patients who have experienced a humoral (antibody mediated) rejection with a hemodynamic compromise during period 1
    5. Patients with a hemoglobin count < 8,0 g/dl (5.0 mmol/l); and/or a platelet count < 50 x 109/l and/or white blood cell count < 2.5 x 109/l)
    6.Patients with total cholesterol (TC) >9 mmol/l and or triglycerides (TG) >6 mmol/l despite lipid lowering treatment
    7.Patients with ongoing wound healing problems or other severe surgical complication in the opinion of the investigator
    8.Patient with a current clinically severe systemic infection
    E.5 End points
    E.5.1Primary end point(s)
    •Measured Glomerular Filtration Rate (mGFR),Cr-EDTA clearance at week 7-11 and at 12 months
    •Development of CAV : Intravascular Ultrasound (IVUS) and Virtual Histology (VH)
    •Number of rejections
    •Number of treatment failures
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 Information not present in EudraCT
    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
    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
    E.8.9.2In all countries concerned by the trial months2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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 Decision2009-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-17
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