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    Summary
    EudraCT Number:2012-000441-12
    Sponsor's Protocol Code Number:0624-201
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-06-11
    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 ConcernedGermany - PEI
    A.2EudraCT number2012-000441-12
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled pilot study to evaluate the safety and effect of Cinryze (C1 Esterase Inhibitor (Human)) for the treatment of acute antibody-mediated rejection in recipients of donor-sensitized kidney transplants.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized pilot study to evaluate the safety and efficacy of Cinryze (C1-Esterase Inhibitor (human)) for the treatment of graft rejection in kidney transplant patients
    A.4.1Sponsor's protocol code number0624-201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01147302
    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 SponsorVIROPHARMA Incorporated
    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 supportViropharma Incorporated
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationViropharma Incorporated
    B.5.2Functional name of contact pointMedical Monitoring
    B.5.3 Address:
    B.5.3.1Street Address730 Stockton Drive
    B.5.3.2Town/ cityEXTON
    B.5.3.3Post codePA 19341
    B.5.3.4CountryUnited States
    B.5.4Telephone number001610321-2354
    B.5.5Fax number001610458-7380
    B.5.6E-mailmarc.uknis@viropharma.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 Cinryze 500 Units powder and solvent for solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderVIROPHARMA SPRL
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNC1 Esterase Inhibitor (human)
    D.3.9.2Current sponsor codeVP20624
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Antibody Mediated Rejection (AMR) in kidney transplant patients
    E.1.1.1Medical condition in easily understood language
    Graft rejection in kidney transplant patients
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10044439
    E.1.2Term Transplant rejection
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Assessment of the safety and tolerability of Cinryze in kidney transplant patients with acute antibody-mediated rejection (AMR).

    - Assessment of the efficacy of Cinryze for the treatment of acute AMR in kidney transplant patients.

    - Examination of the pharmacokinetics and pharmacodynamics of Cinryze in kidney transplant patients with acute AMR.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - age : 18 years or older
    - weight : above or equal to 50 kg
    - Identified Human Leukocyte Antigen (HLA) donor-specific antibody (DSA)
    - Achievement of adequate function of kidney transplant, as determined by creatinine clearance above or equal to 40 ml/min, within the first 4 weeks post-transplant
    - First qualifying AMR episode, within 12 months after transplant
    - Able to receive first dose of study drug, within 72 hours after the qualifying renal allograft biopsy that was diagnostic for AMR
    E.4Principal exclusion criteria
    - have received a deceased donor kidney with any of the following characteristics (Banff classification >=2 for arteriosclerosis, interstitial fibrosis or tubular atrophy ; pediatric and bloc kidney transplant)
    - Rapid onset of severe oliguric AMR
    - Any surgical or medical condition that could interfere with the administration of study drug or interpretation of study results
    - Any infection that causes hemodynamic compromise
    - History of abnormal bleeding, clotting or any coagulopathy
    - History of allergic reaction to C1 esterase inhibitor or other blood products
    - Participation in the active dosing phase of any other investigational drug study within 30 days prior to dosing with the study drug
    - Pregnancy or breastfeeding
    - Within 48 hours prior to dosing with study drug, white blood cell count < 0.5*10e9/l or > 20*10e9/l
    - Within 48 hours prior to dosing with study drug, platelet count < 25*10e9/l or > 600*10e9/l
    - Receipt of any of the following AMR agents, within one month prior to the first dose of study drug : Eculizumab, Ecallantide, Bortezomib, any C1 esterase inhibitor
    E.5 End points
    E.5.1Primary end point(s)
    - Histopathology
    - Graft function (creatinine clearance, serum creatinine)
    - Rescue therapy (salvage spenectomy, plasmapheresis frequency)
    - Clinical (allograft failure, overall survival)
    E.5.1.1Timepoint(s) of evaluation of this end point
    - At Day 20, histopathology.
    - At the end of the study, incidence of salvage splenectomy and clinical end-points (allograft failure, overall survival).
    - Graft function at Days 3,5,7,9,11, 20 and 90
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA2
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Last Patient Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 19
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 20
    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)
    There are no plan for treatment with Cinryze after the subject has ended his/her participation in the trial. Subjects will continue standard of care treatment.
    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 Decision2012-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-28
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