<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/NCT04404127</url>
  </required_header>
  <id_info>
    <org_study_id>RAC # 2191177</org_study_id>
    <nct_id>NCT04404127</nct_id>
  </id_info>
  <brief_title>Standard Induction With Basiliximab Versus No-Induction in Low Immunological Risk Kidney Transplant Recipients</brief_title>
  <official_title>Standard Induction With Basiliximab Versus No-Induction in Low Immunological Risk Kidney Transplant Recipients - Prospective Randomized Double Blind Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Faisal Specialist Hospital &amp; Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Faisal Specialist Hospital &amp; Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Induction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first line agent&#xD;
      in low immunological risk kidney transplant recipients. However, the role of IL2-RA in the&#xD;
      setting of tacrolimus-based immunosuppression has not fully investigated&#xD;
&#xD;
      Aims:&#xD;
&#xD;
      To compare different induction therapeutic strategies with 2 doses of Basiliximab vs. no&#xD;
      induction) in low immunologic risk kidney transplant recipients as per KFSHRC protocol&#xD;
      (Appendix 2)&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Prospective, randomized, double blind, non-inferiority, controlled clinical trial&#xD;
&#xD;
      Expected Outcomes:&#xD;
&#xD;
        1. Primary outcomes:&#xD;
&#xD;
           Biopsy proven acute rejection within first year following transplant&#xD;
&#xD;
        2. Secondary outcomes:&#xD;
&#xD;
             1. Patient and graft survival at 1 year&#xD;
&#xD;
             2. Estimated glomerular filtration rate (eGFR) at 6 months and at 12 months&#xD;
&#xD;
             3. Emergence of de novo donor specific antibodies (DSAs)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">May 2025</completion_date>
  <primary_completion_date type="Anticipated">May 2023</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>The trial will be blinded with respect to Basiliximab induction allocation. The study will be blinded to subjects and site study investigators, with the following exceptions:&#xD;
A single pharmacist A single biostatistician Patients with receive either basiliximab or an intravenous piggyback (IVPB) with normal saline depending on their allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of biopsy proven acute rejection within first year following transplant</measure>
    <time_frame>1 year after transplant</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of graft survival at 1 year</measure>
    <time_frame>1 year after transplant</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of decline in eGFR at 6 months and at 12 months</measure>
    <time_frame>1 year after transplant</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of emergence of de novo donor specific antibodies (DSAs)</measure>
    <time_frame>1 year after transplant</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Kidney Transplantation</condition>
  <arm_group>
    <arm_group_label>No induction Arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Induction with basiliximab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Basiliximab 20 milligram [Simulect]</intervention_name>
    <description>Basiliximab</description>
    <arm_group_label>Induction with basiliximab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <description>No-Induction</description>
    <arm_group_label>No induction Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Male or female ≥ 18 years&#xD;
&#xD;
               -  Living donor&#xD;
&#xD;
               -  Low immunological risk (defined as):&#xD;
&#xD;
                    1. First (primary) transplant&#xD;
&#xD;
                    2. ≤ 4 antigen mismatches (HLA matching scheme)&#xD;
&#xD;
                    3. Negative HLA Ab screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • High immunological risk&#xD;
&#xD;
               -  HLA identical or zero mismatched transplants&#xD;
&#xD;
               -  Receiving cyclosporin as primary maintenance immunosuppressant&#xD;
&#xD;
               -  Human immunodeficiency virus (HIV) co-infection&#xD;
&#xD;
               -  Pregnant or nursing female&#xD;
&#xD;
               -  Has received an investigational medication within the past 30 days&#xD;
&#xD;
               -  Has a known contraindication to the administration of Basiliximab&#xD;
&#xD;
               -  Suspected or known to have a serious infection&#xD;
&#xD;
               -  Multi-organ transplant&#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>King Faisal Specialist Hospital and Research Centre (KFSHRC)</name>
      <address>
        <city>Riyadh</city>
        <zip>11211</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aziza Ajlan, B.Sc. Pharm. BCPS</last_name>
      <phone>966114647272</phone>
      <phone_ext>80341</phone_ext>
      <email>aajlan@kfshrc.edu.sa</email>
    </contact>
    <investigator>
      <last_name>Aziza Ajlan, B.Sc. Pharm. BCPS</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hassan Aleid</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tariq Ali</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hala Joharji</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ahmed Nazmi</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Khalid Almeshari</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Edward Devol</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dalal Alkortas,</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Zinah Alabdulkarim</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yaser Shah</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ibrahim Alahmadi</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Asad Ullah</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ahmed Aljedai</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>February 16, 2021</last_update_submitted>
  <last_update_submitted_qc>February 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Faisal Specialist Hospital &amp; Research Center</investigator_affiliation>
    <investigator_full_name>Aziza Ajlan</investigator_full_name>
    <investigator_title>Aziza A. Ajlan, B.Sc. Pharm. BCPS. Clinical pharmacy specialist- Solid Organ Transplant</investigator_title>
  </responsible_party>
  <keyword>basiliximab</keyword>
  <keyword>Rejection</keyword>
  <keyword>De no vo donor specific antibodies</keyword>
  <keyword>Low immunological risk</keyword>
  <keyword>Induction</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Basiliximab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04404127
org study id: RAC # 2191177
nct id: NCT04404127
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Background:

      Induction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first line agent
      in low immunological risk kidney transplant recipients. However, the role of IL2-RA in the
      setting of tacrolimus-based immunosuppression has not fully investigated

      Aims:

      To compare different induction therapeutic strategies with 2 doses of Basiliximab vs. no
      induction) in low immunologic risk kidney transplant recipients as per KFSHRC protocol
      (Appendix 2)

      Methods:

      Prospective, randomized, double blind, non-inferiority, controlled clinical trial

      Expected Outcomes:

        1. Primary outcomes:

           Biopsy proven acute rejection within first year following transplant

        2. Secondary outcomes:

             1. Patient and graft survival at 1 year

             2. Estimated glomerular filtration rate (eGFR) at 6 months and at 12 months

             3. Emergence of de novo donor specific antibodies (DSAs)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: The trial will be blinded with respect to Basiliximab induction allocation. The study will be blinded to subjects and site study investigators, with the following exceptions:
A single pharmacist A single biostatistician Patients with receive either basiliximab or an intravenous piggyback (IVPB) with normal saline depending on their allocation.
measure: Rate of biopsy proven acute rejection within first year following transplant
time frame: 1 year after transplant
measure: Rate of graft survival at 1 year
time frame: 1 year after transplant
measure: Rate of decline in eGFR at 6 months and at 12 months
time frame: 1 year after transplant
measure: Rate of emergence of de novo donor specific antibodies (DSAs)
time frame: 1 year after transplant
arm group label: No induction Arm
arm group type: Placebo Comparator
arm group label: Induction with basiliximab
arm group type: Active Comparator
intervention type: Drug
intervention name: Basiliximab 20 milligram [Simulect]
description: Basiliximab
arm group label: Induction with basiliximab
intervention type: Other
intervention name: Normal Saline
description: No-Induction
arm group label: No induction Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: King Faisal Specialist Hospital & Research Center
investigator full name: Aziza Ajlan
investigator title: Aziza A. Ajlan, B.Sc. Pharm. BCPS. Clinical pharmacy specialist- Solid Organ Transplant
mesh term: Basiliximab
sharing ipd: No