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    The EU Clinical Trials Register currently displays   39233   clinical trials with a EudraCT protocol, of which   6427   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2014-004102-15
    Sponsor's Protocol Code Number:0468H-102012
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-04-06
    Trial results View results
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    A. Protocol Information
    A.2EudraCT number2014-004102-15
    A.3Full title of the trial
    An open label comparative study of de novo renal allograft recipients receiving CsA + MMF + corticosteroids versus CsA + Rapamune + corticosteroids with further CsA elimination in the
    Rapamune arm with the introduction of MMF.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open Label Comparative Study Of De Novo Renal Allograft Recipients Receiving CSA + MMF + Corticosteroids Versus CSA + Rapamune + Corticosteroids
    A.4.1Sponsor's protocol code number0468H-102012
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01601821
    A.5.4Other Identifiers
    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
    B.1.3.4CountryIran, Islamic Republic of
    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.4.2CountryIran, Islamic Republic of
    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 number18007181021
    B.5.5Fax number13037391119
    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. name Rapamune
    D. of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationIran, Islamic Republic of
    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
    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.3.9.2Current sponsor code0468
    D.3.9.4EV Substance CodeSUB10537MIG
    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) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Renal Transplantation
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10038533
    E.1.2Term Renal 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 incidence of biopsy-confirmed acute rejection, graft loss, or death within 12 months post-transplantation between the treatment arm A (CsA+Rapamune+CS) and treatment arm B (CsA+MMF+CS).
    E.2.2Secondary objectives of the trial
    To compare serum creatinine at 3, 6 and 12 months after transplantation.
    To compare Glomerular Filtration Rate (GFR) (Nankivell method) at 3, 6 and 12 months after transplantation.
    To compare incidence of biopsy-confirmed acute rejection at 6 months following transplantation.
    To compare histologic grade of first acute rejection.
    To compare subject and graft survival at 12 months after transplantation.
    To compare incidence of infections, histologically-confirmed lymphoproliferative disease and anemia at 12 months after transplantation.
    To compare incidence of efficacy failure or treatment failure.
    To compare number of subjects discontinuing assigned therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age greater than or equal to (>=) 13 years and weight >=40 kg.
    2. End-stage renal disease, with subjects receiving a primary or secondary renal allograft from a living-unrelated donor, or from a living-related donor.
    3. Women who are of childbearing potential must have a negative pregnancy test before enrollment in the study and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation from the study.
    4. Total white blood cell count >= 4.0 x 109/ Liter (L) (4,000/millimeter (mm) P^3) platelet count ≥ 100 x 10^9/L (100,000/mm ^3), fasting triglycerides greater than or equal to <=4.6 miliimole per liter (mmol/L) (400 milligram per deciliter [mg/dL]), fasting cholesterol <= 7.8 mmol/L (300 mg/dL). If it is not possible to obtain fasting triglycerides and cholesterol before surgery, historical values (within 1 year) may be used.
    5. Signed and dated informed consent (parent or legal guardian must provide consent for subjects less than (<) 18 years of age). An assent form will be signed by subjects < 18 years of age enrolled in the study.
    E.4Principal exclusion criteria
    1. Evidence of active systemic or localized major infection at the time of initial Sirolimus administration.
    2. Cadaveric donors
    3. History of malignancy within 5 years before enrollment into the study (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin)
    4. Use of any investigational drug other than specified in the protocol during the 4 weeks before enrolling in the study.
    5. Use of planned antibody induction therapy at the time of transplantation.
    6. Active gastrointestinal disorder that may interfere with drug absorption.
    7. Known hypersensitivity to Sirolimus, Mycophenolat Mofetil (MMF) or Cyclosporine or its derivatives.
    8. Multiple organ transplants (2 or more organ transplant e.g. Kidney and Pancreas).
    9. Subject with high risk of rejection (eg. subjects with a PRA greater than (>) 50 percent (%), black subjects and subjects with 2nd transplant who lost their first graft within the first 6 months).
    10. Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of Efficacy Failure
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline up to Month 12
    E.5.2Secondary end point(s)
    1. Serum Creatinine Level
    2. Creatinine Clearance
    3. Glomerular Filtration Rate (GFR) by Nankivell Method
    4. Incidence of Biopsy-Confirmed Acute Rejection
    5. Histologic Grade of First Acute Rejection
    6. Percentage of subjects Who Survived
    7. Percentage of subjects With Graft Survival
    8. Incidence of Presumptive or Documented Infection
    9. Incidence of Histologically Confirmed Lymphoproliferative Disease
    10. Percentage of Subjects With Efficacy Failure or Premature Elimination
    11. Incidence of Anemia
    12. Number of Subjects Who Discontinued
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Month 3, 6, 12
    2. Month 3, 6, 12
    3. Month 3, 6, 12
    4. Baseline up to Month 6
    5. Baseline up to Month 12
    6. Month 12
    7. Month 12
    8. Baseline up to Month 12
    9. Baseline up to Month 12
    10. Month 12
    11. Baseline up to Month 12
    12. Month 12
    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. 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. description
    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 Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Iran, Islamic Republic of
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days24
    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: 245
    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. of subjects for this age range: 9
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 228
    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 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. of subjects incapable of giving consent
    Subjects aged 13 to 17 years.
    F.3.3.7Others Yes
    F. of other specific vulnerable populations
    Subjects aged 13 to 17 years.
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 245
    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)
    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: Iran, Islamic Republic of
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