<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03228576</url>
  </required_header>
  <id_info>
    <org_study_id>TREVISE</org_study_id>
    <nct_id>NCT03228576</nct_id>
  </id_info>
  <brief_title>Prospective Cohort of Kidney Transplanted Patients Receiving an Extended Releasing Tacrolimus-Everolimus Association</brief_title>
  <official_title>Observationnal Multicenter Study on a Prospective Cohort of Kidney Transplanted Patients Receiving a Year After Transplant an Extended Releasing Tacrolimus-Everolimus Association</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poitiers University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chiesi Farmaceutici S.p.A.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Poitiers University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The tacrolimus-Everolimus association is used as an immunospressive treatment after a kidney&#xD;
      transplant. It combined immunosupressive properties of both products and reduce the&#xD;
      nephrotoxicity of tacrolimus by lowering the dosage.&#xD;
&#xD;
      The commercialisation of a new extended release Tacrolimus pharmaceutical form and the lack&#xD;
      of information justify a modality of use and tolerence evaluation of this new association,&#xD;
      commonly used.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    No recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">April 14, 2017</start_date>
  <completion_date type="Actual">December 18, 2018</completion_date>
  <primary_completion_date type="Actual">December 18, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Tolerance of the Certican®-Envarsus® association</measure>
    <time_frame>During 1 year, between each visit (J0, M3, M6, M9, M12)</time_frame>
    <description>Assess clinical and biological tolerance of the Certican®-Envarsus® association on kidney transplanted patient, one year after transplant : study of adverse events with biological results (biochimy, hematology).&#xD;
Study of incidence of Treatment-Emergent Adverse Events.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients description</measure>
    <time_frame>1 year</time_frame>
    <description>Describe the profil of included patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinical evolution</measure>
    <time_frame>1 year</time_frame>
    <description>Describe the patients clinical evolution after a one year follow up : adverse events, renal function (creatinine)...</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment</measure>
    <time_frame>1 year</time_frame>
    <description>Describe treatments and switch modalities : tolerability with adverse events, conversion value between Prograf® and Envarsus®</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal function</measure>
    <time_frame>1 year</time_frame>
    <description>Describe the evolution of renal function during follow up : creatinine value during the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Graft Rejections and survival rates</measure>
    <time_frame>1 year</time_frame>
    <description>Assess acute graft rejections (confirmed by a biopsy with the Banff classification and creatinine value) and transplants survival rates a year after the switch : all renal biopsies will be reported, with the reason for the biopsy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication compliance</measure>
    <time_frame>1 year</time_frame>
    <description>Assess medication compliance during the switch and by the end of the study, to evaluated by doctor by asking the patient and with pharmacological concentrations (used in nephrology)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">16</enrollment>
  <condition>Kidney Transplant</condition>
  <condition>Immunosuppression</condition>
  <arm_group>
    <arm_group_label>TREVISE</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Extended release Tacrolimus-Everolimus association</intervention_name>
    <description>Envarsus® will be used as Tacrolimus Certican® will be used as Everolimus</description>
    <arm_group_label>TREVISE</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients over 18 years old with kidney transplantation for at least one year.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years old&#xD;
&#xD;
          -  Patients informed and giving his agreement to the use of every collected data&#xD;
&#xD;
          -  Patients with kidney transplantation for at least one year and being treated with the&#xD;
             immunosppressive assiociation of Tacrolimus (Prograf ®)-Everolimus&#xD;
&#xD;
          -  Patients whose investigators decides to switch from Prograf ® to an Envarsus&#xD;
             ®-Everolimus association&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other transplantation&#xD;
&#xD;
          -  Drug or alcohol abuse&#xD;
&#xD;
          -  Patients unable to understand the purpose or modalities of this study, unable to give&#xD;
             his agreement or unable to stick to the protocol&#xD;
&#xD;
          -  Patients on an interventionnal protocol when included&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Amiens University Hospital</name>
      <address>
        <city>Amiens</city>
        <zip>80000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Angers University Hospital</name>
      <address>
        <city>Angers</city>
        <zip>49100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Caen University Hospital</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clermont Ferrand University Hospital</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <zip>86000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rennes University Hospital</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rouen University Hospital</name>
      <address>
        <city>Rouen</city>
        <zip>76000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Strasbourg University Hospital</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tours University Hospital</name>
      <address>
        <city>Tours</city>
        <zip>37000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>June 23, 2017</study_first_submitted>
  <study_first_submitted_qc>July 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>August 23, 2019</last_update_submitted>
  <last_update_submitted_qc>August 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tacrolimus</keyword>
  <keyword>Envarsus</keyword>
  <keyword>Everolimus</keyword>
  <keyword>kidney</keyword>
  <keyword>Transplant</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Everolimus</mesh_term>
    <mesh_term>Tacrolimus</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03228576
org study id: TREVISE
nct id: NCT03228576
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The tacrolimus-Everolimus association is used as an immunospressive treatment after a kidney
      transplant. It combined immunosupressive properties of both products and reduce the
      nephrotoxicity of tacrolimus by lowering the dosage.

      The commercialisation of a new extended release Tacrolimus pharmaceutical form and the lack
      of information justify a modality of use and tolerence evaluation of this new association,
      commonly used.
observational model: Cohort
time perspective: Prospective
measure: Tolerance of the Certican®-Envarsus® association
time frame: During 1 year, between each visit (J0, M3, M6, M9, M12)
description: Assess clinical and biological tolerance of the Certican®-Envarsus® association on kidney transplanted patient, one year after transplant : study of adverse events with biological results (biochimy, hematology).
Study of incidence of Treatment-Emergent Adverse Events.
measure: Patients description
time frame: 1 year
description: Describe the profil of included patients
measure: clinical evolution
time frame: 1 year
description: Describe the patients clinical evolution after a one year follow up : adverse events, renal function (creatinine)...
measure: Treatment
time frame: 1 year
description: Describe treatments and switch modalities : tolerability with adverse events, conversion value between Prograf® and Envarsus®
measure: Renal function
time frame: 1 year
description: Describe the evolution of renal function during follow up : creatinine value during the study
measure: Graft Rejections and survival rates
time frame: 1 year
description: Assess acute graft rejections (confirmed by a biopsy with the Banff classification and creatinine value) and transplants survival rates a year after the switch : all renal biopsies will be reported, with the reason for the biopsy.
measure: Medication compliance
time frame: 1 year
description: Assess medication compliance during the switch and by the end of the study, to evaluated by doctor by asking the patient and with pharmacological concentrations (used in nephrology)
arm group label: TREVISE
intervention type: Combination Product
intervention name: Extended release Tacrolimus-Everolimus association
description: Envarsus® will be used as Tacrolimus Certican® will be used as Everolimus
arm group label: TREVISE
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Everolimus
mesh term: Tacrolimus