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    Summary
    EudraCT Number:2006-005687-44
    Sponsor's Protocol Code Number:0468H1-316
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-04-10
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2006-005687-44
    A.3Full title of the trial
    A Randomized, Open-Label, Comparative Evaluation of Conversion From Calcineurin Inhibitors to Sirolimus Versus Continued Use of Calcineurin Inhibitors in Renal Allograft Recipients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant
    A.4.1Sponsor's protocol code number0468H1-316
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00038948
    A.5.4Other Identifiers
    Name:aliasNumber:B1741186
    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 SponsorWyeth Research
    B.1.3.4CountryUnited States
    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 supportWyeth Research
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number8007181021
    B.5.5Fax number3037391119
    B.5.6E-mailClinicalTrials.govCallCenter@pfizer.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 Yes
    D.2.1.1.1Trade name Rapamune
    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 Tablet and powder for oral solution
    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.3.8INN - Proposed INNSIROLIMUS
    D.3.9.1CAS number 53123-88-9
    D.3.9.3Other descriptive namerapamycin
    D.3.9.4EV Substance CodeSUB10537MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSIROLIMUS
    D.3.9.1CAS number 53123-88-9
    D.3.9.3Other descriptive namerapamycin
    D.3.9.4EV Substance CodeSUB10537MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Renal Transplantation
    E.1.1.1Medical condition in easily understood language
    Kidney Transplantation
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    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
    To determine the effect of conversion from calcineurin inhibitor (CI)- to sirolimus (SRL)-based therapy on renal function 52 weeks after randomization, as indicated by the change from baseline calculated glomerular filtration rate (GFR) (Nankivell method), and to demonstrate:
    a)superiority of the SRL conversion versus CI continuation regimens in subjects with baseline Nankivell GFRs greater than (>) 40 milliliter per minute (mL/min). OR
    b)noninferiority of the SRL conversion versus CI continuation regimens in subjects with baseline Nankivell GFRs of 20 to 40 mL/min, and to establish superiority in this group if the results are consistent with this conclusion.
    To assess equivalence 52 weeks after randomization between treatment groups in the composite endpoint of the incidence of the first occurrence of biopsy-confirmed acute rejection, graft loss, or death.
    E.2.2Secondary objectives of the trial
    Change from baseline in the on-therapy Nankivell GFR at 24, 52, 104, 156 and 208 weeks. The least squares slopes of 1/creatinine vs time at 24, 52, 104, 156 and 208 weeks. The least squares slopes of the plot of Nankivell GFR vs time at 24, 52, 104, 156 and 208 weeks. The change from baseline in GFR as measured by radionuclide or comparable techniques at 52, 104 and 208 weeks (at selected centers). The incidence and severity of biopsy-confirmed acute rejection at 24, 52, 104,156 and 208 weeks. Patient and graft survival at 24, 52, 104, 156 and 208 weeks. The incidence of treatment failure, defined as the occurrence of acute rejection or premature withdrawal from study medication for any reason by weeks 52, 104, 156 and 208. The change from baseline in mean systolic and diastolic blood pressure and mean calculated arterial pressure . Quality of life outcomes . The change from baseline in the severity and progression of biopsy-confirmed chronic allograft nephropathy (CAN).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age greater than equal to (≥) 13 years.
    2. Treatment with corticosteroids (dosage range 2.5 to 15 milligrams / day (mg/day) for prednisone or prednisolone (2 to 12 mg/day for methylprednisolone) or the alternate day equivalent) and either mycophenolate mofetil (MMF) (≥500 mg/day) or azathioprine (AZA) (≥50 mg/day) for a minimum of 12 weeks before randomization.
    3. Receiving either cyclosporin A (CsA) or tacrolimus from the time of transplantation or within 2 weeks thereafter.
    4. Subjects with a functioning allograft and a Nankivell glomerular filtration rate (GFR) ≥ 40 milliliter/ minute (mL/min), within 2 weeks before randomization.
    5. Six to 120 months after renal transplantation.
    6. Greater than 12 weeks after treatment for any acute rejection.
    7. Renal biopsy within 16 weeks before randomization.
    8. All female Subjects at risk for pregnancy must have a negative serum pregnancy test before randomization. Female Subjects at risk for pregnancy must agree to use a medically acceptable method of contraception throughout the treatment period and for 12 weeks after discontinuation of study medication.
    9. Total white blood cell count greater than (>) 3000/mm 3 [>3.0 * 109/Liter (L)], platelet count >100,000/mm 3(>100 * 109/L), fasting triglycerides <350 mg/dL [<3.95 millimoles/liter (mmol/L)], fasting cholesterol less than (<) 300 milligrams/ deciliter (mg/dL) (<7.8 mmol/L).
    10. Signed and dated independent ethics committee (IEC)- approved informed consent before screening and before any protocol specified tests. A parent or legal guardian must provide written consent for Subjects younger than the age of majority as defined by state and local laws. Subjects younger than the age of majority may also sign an assent form.

    E.4Principal exclusion criteria
    1.Clinically diagnosed or biopsy-confirmed acute rejection, as diagnosed by the Banff 97 classification within 12 weeks before randomization, that was determined to require anti-rejection treatment.
    2.Serum creatinine at the time of screening that has increased by >30 percent (%) above the last value obtained at least 12 weeks earlier.
    3.Subjects in whom kidney-pancreas or other multiple organ transplants have been performed.
    4.Evidence of systemic infection at the time of randomization.
    5.Presence of unstable angina or use of ongoing maintenance therapy for a life-threatening arrhythmia.
    6.Known or suspected malignancy (with the exception of adequately treated basal cell or squamous cell carcinomas of the skin) less than equal to (≤5) years before randomization or any history of posttransplant lymphoproliferative disease (PTLD).
    7.Prior or current use of SRL or any of its derivatives.
    8.Use of investigational agents ≤4 weeks before randomization.
    9.Use of immunosuppressive agents (at the time of randomization)
    10.Current use of terfenadine, cisapride, astemizole, pimozide, or cimetidine; these drugs must be discontinued before randomization. Cimetidine must be discontinued before the screening examination.
    11.Positive past medical history for documented human immunodeficiency virus (HIV)infection.
    E.5 End points
    E.5.1Primary end point(s)
    Nankivell Glomerular Filtration Rate (GFR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    E.5.2Secondary end point(s)
    First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 and 104 weeks
    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) 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Chile
    Czech Republic
    Denmark
    France
    Germany
    Italy
    Mexico
    Poland
    Portugal
    Saudi Arabia
    South Africa
    Spain
    Sweden
    United States
    E.8.7Trial has a data monitoring committee No
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days17
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 38
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 38
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 745
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 41
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    pediatric subjects
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 824
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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