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    Summary
    EudraCT Number:2006-003633-32
    Sponsor's Protocol Code Number:CERL080A2419
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-01-18
    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 ConcernedAustria - BASG
    A.2EudraCT number2006-003633-32
    A.3Full title of the trial
    A randomized, multi-center, parallel-group, open-label study to evaluate the therapeutical benefit of an initially intensified dosing regimen of Myfortic® vs. a standard dosing regimen of Myfortic® in combination with Neoral® and Corticosteroids in de novo renal transplant patients
    A.4.1Sponsor's protocol code numberCERL080A2419
    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 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 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 Myfortic
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameMyfortic
    D.3.2Product code ERL 080A
    D.3.4Pharmaceutical form Gastro-resistant tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) 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
    Prophylaxis of rejection in recipients of first or second cadaveric, living unrelated or living related kidney transplants
    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
    The main aim of the study is to confirm the hypothesis than an initially intensified dosing regimen of mycophenolic acid administered as Myfortic® during the first 6 weeks post transplantation will provide therapeutical benefit as compared to a standard dosing regimen of Myfortic®, and is as safe and well-tolerated as the standard dosing regimen of Myfortic®.
    E.2.2Secondary objectives of the trial
    To compare proportion of patients with treatment failure (defined as biopsy proven rejection, graft failure or death) at days 21 and 84 post-transplantation.

    To compare renal function as assessed by serum creatinine and glomerular filtration rate.

    To compare safety/tolerability as the proportion of patients with Myfortic® dose reductions and interruptions due to AEs, within 6 months post-transplantation.

    To explore changes in patient-reported gastro intestinal symptom burden using the Gastrointestinal Symptom Rating Scale (GSRS) total score at visits baseline, day 10, day 21, day 56, and day 84 post-transplantation.

    To explore changes in patient-reported health status measured by EQ-5D in at visits baseline, day 10, day 21, day 56, day 84 and day 180 post-transplantation.

    To compare the proportion of patients with treatment failure between treatment arms combining this study data with the data from CERL080ADE12 and with in-house historical data.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Pharmacokinetic substudy (18-Aug-2006)

    To explore the pharmacokinetics of mycophenolic acid, mycophenolic acid glucuronide and free MPA in a subgroup of de novo renal transplant patients (in selected centers only).

    2. Pharmacogenetic substudy (18-Aug-2006)

    To explore the influence of uridine diphosphate-glucuronosyltranferase 1A9 (UGT1A9) and multidrug resistance protein 2 (MRP2) single nucleotide polymorphisms (SNPs) on the risk of acute rejection due to an early under-exposure in the standard Myfortic® dosing regimen versus the initially intensified Myfortic® dosing regimen as well as to explore the role of these SNPs on the risk for developing MPA-related side-effects.
    E.3Principal inclusion criteria
    1. Males or females, aged between 18 and 65 years
    2. Recipients of first or second cadaveric, living unrelated or living related kidney transplants
    3. Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at Baseline (Visit 1), and are required to practice an approved method of birth control for the duration of the study and for a period of 3 months following discontinuation of study medication, even where there has been a history of infertility
    4. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained
    E.4Principal exclusion criteria
    1. Graft loss due to immunological reasons in the first year after the first transplantation (in case of secondary transplantation)
    2. Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
    3. Patients receiving a kidney from a non-heart beating donor
    4. Patients who are recipients of A-B-O incompatible transplants
    5. Patients with a current peak PRA of > 10%
    6. Patients with already existing antibodies against the HLA-type of the receiving transplant
    7. Patients with any known hypersensitivity to mycophenolic acid or cyclosporine micro-emulsion, or other components of the formulations (e.g. lactose, see also SmPCs)
    8. Use of other investigational drugs or a non-protocol immunosuppressant at randomization, or within 30 days or 5 half-lives prior to randomization, whichever is longer
    9. Patients with thrombocytopenia (platelets < 100,000/mm³), with an absolute neutrophil count of < 2,000/mm³ or leucopenia (leucocytes < 3,000/mm³), or hemoglobin < 6 g/dL
    10. Patients with symptoms of significant mental illness. Inability to cooperate or communicate with the investigator, who are unlikely to comply with the study requirements, or who are unable to give informed consent
    11. Patients with a history of malignancy during the last five years, except squamous or basal cell carcinoma of the skin
    12. Patients who are HIV positive or Hepatitis B surface antigen positive.
    13. Evidence of severe liver disease (incl. abnormal liver enzyme profile, i.e. AST, ALT or total bilirubin > 3 times UNL)
    14. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception (see also section 8.2)
    15. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy or are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, hysterectomy), hormonal contraception (implantable, patch, oral), and double- barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 3 months after study drug discontinuation
    16. Presence of a clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus that in the opinion of the investigator would interfere with the appropriate conduct of the study
    17. Evidence of drug or alcohol abuse
    18. Patients receiving drugs known as strong inhibitors or inducers of CsA and/or Myfortic® drug metabolism (for drug interactions see Appendix 3 to this protocol).
    19. Patients with chronic bowel inflammatory disease.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the proportion of patients with treatment failure defined as biopsy-proven acute rejection (BPAR), graft loss (GFL) or death at 6 months post-transplantation.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    patient reported outcomes and quality of life
    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.8.2.3.1Comparator description
    Standard dose of myfortic
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    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) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-01-18. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    as per exclusion criteria
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    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)
    Discontinuing patients will be treated according to local pratice but the patients will be followed throughout the remainder of the study.
    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 Decision2007-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-07-30
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