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    Summary
    EudraCT Number:2005-001183-31
    Sponsor's Protocol Code Number:MT18328
    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:2005-09-08
    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 number2005-001183-31
    A.3Full title of the trial
    A prospective, open label, randomized, multicenter, multinational study evaluating the overall efficacy and safety including the effect on renal function of sirolimus (Rapamune) replacing CNI in a standard care regimen of CNI, mycophenolate mofetil (MMF) and steroids in heart transplant patients
    A.3.2Name or abbreviated title of the trial where available
    Heart STN
    A.4.1Sponsor's protocol code numberMT18328
    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 SponsorF. Hoffmann-La Roche Ltd
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Rapamune
    D.2.1.1.2Name of the Marketing Authorisation holderAHP (Schweiz) AG, Wyeth Division, Grafenauweg 10, 6301 Zug
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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 nameRapamune
    D.3.4Pharmaceutical form Coated 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.3.8INN - Proposed INNSirolimus
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeselective immunosuppressant agents
    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 Transplant
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Classification code 10019314
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate efficacy and safety, including the effect on renal function of sirolimus (Rapamune) replacing CNI after 3 months in a standard care regimen of CNI, MMF and steroids compared to a standard care regimen of CNI, MMF and steroids in heart transplant patients
    E.2.2Secondary objectives of the trial
    •Incidence of BPAR (and freedom from BPAR) at 6, 12 and 24 months
    •Number of episodes of BPAR per patient at 6, 12, and 24 months
    •Time to first BPAR
    •Incidence of re-transplant at 6, 12 and 24 months
    •Incidence of death at 6, 12 and 24 months
    •Incidence of treated rejection including antibody treated rejection
    •Incidence of antibody treated rejection (and freedom from antibody treated rejection)
    •Incidence of any episode of rejection associated with HDC
    •Time to graft loss at 6, 12 and 24 months
    •Time to death at 6, 12 and 24 months
    •Time to composite primary endpoint
    •IVUS end points at 12 months
    •Incidence of treatment failure at 12 and 24 months
    •Renal function assessed by calculated GFR
    •Renal function defined by the difference in the slope of the 1/ SCr. plot at 6, 12 and 24 months
    •Protein / creatinine ratio at 6, 12 and 24 months
    •Safety between treatment groups (at 2 years unless otherwise indicated)
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Patients, age > 18
    2. Patients receiving their first heart transplant (single organ transplant)
    3. Patients on a standard care regimen of CNI, MMF and steroids since transplantation
    4. Patients capable of understanding the purposes and risks of the study and who can give written informed consent
    E.4Principal exclusion criteria
    Exclusion Criteria at Study Entry (4-6 weeks post-transplant):
    1. Women of childbearing potential with a positive serum or urine pregnancy test or nursing mothers. Females of childbearing potential not using 2 reliable forms of contraception, including a barrier method, for the duration of the study and for 90 days after the last dose of study medication.
    2. Patients with a positive donor-specific cross-match at the time of transplantation
    3. Patients with any PRA > 25%
    4. Patients with history of malignancy other than non-melanoma skin cancer that has been totally excised and who have shown no recurrence for 2 years
    5. Patients with
    a) Ejection fraction of ≤ 40%
    b) Ejection fraction of 20% decrease from baseline, and the need for inotropic agents
    c) Fractional shortening ≤20% or a 25% decrease from baseline, and the need for inotropic agents
    d) Need for inotropic agents due to a Cardiac Index (CI) <2.0 L/min/m2 or a 25% decrease from baseline
    6. Patients with any antibody treated acute rejection
    7. Patients with known contraindications to treatment with sirolimus
    8. Patients with hemoglobin < 8.5g/dL, WBC value of <3000/mm3 or a platelet count of <50,000/mm3 unlikely to resolve prior to randomization
    9. Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication unlikely to resolve prior to randomization
    10. Patients participating in another interventional clinical trial or requiring treatment with un-marketed investigational drugs or who would be expected to require other medications prohibited by the protocol.
    11. Patients who require revascularization prior to study entry (bypass, stenting, angioplasty)

    Additional Exclusion Criteria at Randomization [12 (+/- 2) weeks post-transplant]:

    1. All exclusion criteria as at Study Entry
    2. Patients no longer on a standard care regimen of CNI, MMF and steroids
    3. Patients not on HMG CoA reductase inhibitors (“statins”)
    4. Patients who require dialysis within 4 weeks prior to randomization
    5. Patients with any biopsy proven acute rejection ≥ ISHLT grade 3A within 4 weeks prior to randomization
    6. Patients with any biopsy proven acute rejection ≥ ISHLT grade 3A more than 4 weeks prior to randomization without a subsequent biopsy of ISHLT grade 0 or IA
    7. Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication
    8. Sepsis or any severe active infection requiring IV antibiotics and/or hospitalization within the 2 weeks prior to randomization
    Patients who received sirolimus before randomization
    E.5 End points
    E.5.1Primary end point(s)
    Renal function (% change from randomization) assessed by calculated GFR utilizing MDRD-6 at 24 months post transplant (21 months post-randomization)
    and
    a composite endpoint of incidence of biopsy proven acute rejection or HDC, or graft loss (re-transplantation or death) or lost to follow-up in the interval between randomization and 12 mos post-transplant (9 mos after randomization).
    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 Information not present in EudraCT
    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) 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 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 No
    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.8.5The 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 Information not present in EudraCT
    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 years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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 Information not present in EudraCT
    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 2005-09-08. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 420
    F.4.2.2In the whole clinical trial 650
    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)
    At the end of the study all patients will be receiving standard immunosuppressive therapy as per center practice.
    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 Decision2005-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-10-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-06-01
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