<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/NCT03789006</url>
  </required_header>
  <id_info>
    <org_study_id>033546</org_study_id>
    <nct_id>NCT03789006</nct_id>
  </id_info>
  <brief_title>Antithymocyte Globulin and Azathioprine Versus Basiliximab and Mycophenolate Mofetil in Living Donor Kidney Transplantation</brief_title>
  <official_title>Efficiency of Antithymocyte Globulin and Azathioprine Versus Basiliximab and Mycophenolate Mofetil When Used in Combination With Tacrolimus and Prednisolone in Living Donor Kidney Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Khartoum</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Kidney Diseases and Surgery</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Khartoum</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Kidney transplantation is the best available treatment option for patients with end stage&#xD;
      renal disease. However, kidney transplantation requires life-long use of immunosuppressive&#xD;
      medication. Because of the high cost of these medications we need to carefully evaluate the&#xD;
      cost-effectiveness of each drug regimen, especially in low-middle income countries. The&#xD;
      objective of this clinical trial is to compare the efficiency and cost of two&#xD;
      immunosuppressive protocols after living donor kidney transplantation: (1) antithymocyte&#xD;
      globulin, tacrolimus, azathioprine and prednisolone versus (2) basiliximab, tacrolimus,&#xD;
      mycophenolate mofetil and prednisolone.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 21, 2018</start_date>
  <completion_date type="Anticipated">March 21, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 21, 2022</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>
    <intervention_model_description>Randomized clinical trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of acute rejection</measure>
    <time_frame>6 months post kidney transplant</time_frame>
    <description>The incidence of acute rejection will include clinically diagnosed and biopsy proven acute rejection. Clinically diagnosed rejection includes at least 30% acute rise in serum creatinine level. Biopsy proven rejection will include both cellular and antibody mediated rejection according to Banff 2017 criteria</description>
  </primary_outcome>
  <primary_outcome>
    <measure>One year graft survival</measure>
    <time_frame>1 year post kidney transplant</time_frame>
    <description>One year kidney allograft survival, uncensored for patient death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cost of immunosuppressive medication</measure>
    <time_frame>1 year post kidney transplant+</time_frame>
    <description>Overall cost of immunosuppressive medication during first year post kidney transplant</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Kidney Transplant Rejection</condition>
  <arm_group>
    <arm_group_label>ATG</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Induction with antithymocyte immunoglobulin (Rabbit) (Grafalon) and maintenance with tacrolimus, azathioprine and prednisolone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BAS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Induction with interleukin 2 receptor antagonist (basiliximab) and maintenance with tacrolimus, mycophenolate mofetil and prednisolone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Antithymocyte Immunoglobulin (Rabbit)</intervention_name>
    <description>Induction agent for living donor kidney transplantation</description>
    <arm_group_label>ATG</arm_group_label>
    <other_name>grafalon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Interleukin 2 Receptor Antagonist</intervention_name>
    <description>Induction agent for living donor kidney transplantation</description>
    <arm_group_label>BAS</arm_group_label>
    <other_name>Basiliximab</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult end-stage renal disease patients&#xD;
&#xD;
          -  First living donor kidney transplant.&#xD;
&#xD;
          -  Moderate immunological risk.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Low immunological risk (HLA mismatches 000/100/010/110 with negative PRA).&#xD;
&#xD;
          -  High immunological risk (child to mother or husband to wife transplant, 2 DR&#xD;
             mismatches).&#xD;
&#xD;
               -  Known hypersensitivity to any of the study medication.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarra Elamin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Consultant Nephrologist</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sarra Elamin, MD</last_name>
    <phone>(+249)912474666</phone>
    <email>sarraelamin@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nazar Zulfo, MD</last_name>
    <phone>(+249)900948820</phone>
    <email>nazarzuflo@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Doctor Salma Center for Kidney Diseases</name>
      <address>
        <city>Khartoum</city>
        <zip>11111</zip>
        <country>Sudan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sarra Elamin, MD</last_name>
      <phone>(+249)912474666</phone>
      <email>sarraelamin@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Nazar Zulfo, MD</last_name>
      <phone>(+249)900948820</phone>
      <email>nazarzuflo@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Sudan</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 25, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>December 31, 2018</last_update_submitted>
  <last_update_submitted_qc>December 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Khartoum</investigator_affiliation>
    <investigator_full_name>Sarra Elamin</investigator_full_name>
    <investigator_title>Consultant Physician and Nephrologist</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Interleukin-2</mesh_term>
    <mesh_term>Immunoglobulins</mesh_term>
    <mesh_term>Immunoglobulins, Intravenous</mesh_term>
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Basiliximab</mesh_term>
    <mesh_term>Thymoglobulin</mesh_term>
    <mesh_term>Antilymphocyte Serum</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03789006
org study id: 033546
nct id: NCT03789006
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Kidney transplantation is the best available treatment option for patients with end stage
      renal disease. However, kidney transplantation requires life-long use of immunosuppressive
      medication. Because of the high cost of these medications we need to carefully evaluate the
      cost-effectiveness of each drug regimen, especially in low-middle income countries. The
      objective of this clinical trial is to compare the efficiency and cost of two
      immunosuppressive protocols after living donor kidney transplantation: (1) antithymocyte
      globulin, tacrolimus, azathioprine and prednisolone versus (2) basiliximab, tacrolimus,
      mycophenolate mofetil and prednisolone.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized clinical trial
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of acute rejection
time frame: 6 months post kidney transplant
description: The incidence of acute rejection will include clinically diagnosed and biopsy proven acute rejection. Clinically diagnosed rejection includes at least 30% acute rise in serum creatinine level. Biopsy proven rejection will include both cellular and antibody mediated rejection according to Banff 2017 criteria
measure: One year graft survival
time frame: 1 year post kidney transplant
description: One year kidney allograft survival, uncensored for patient death
measure: Cost of immunosuppressive medication
time frame: 1 year post kidney transplant+
description: Overall cost of immunosuppressive medication during first year post kidney transplant
arm group label: ATG
arm group type: Active Comparator
description: Induction with antithymocyte immunoglobulin (Rabbit) (Grafalon) and maintenance with tacrolimus, azathioprine and prednisolone
arm group label: BAS
arm group type: Active Comparator
description: Induction with interleukin 2 receptor antagonist (basiliximab) and maintenance with tacrolimus, mycophenolate mofetil and prednisolone
intervention type: Drug
intervention name: Antithymocyte Immunoglobulin (Rabbit)
description: Induction agent for living donor kidney transplantation
arm group label: ATG
other name: grafalon
intervention type: Drug
intervention name: Interleukin 2 Receptor Antagonist
description: Induction agent for living donor kidney transplantation
arm group label: BAS
other name: Basiliximab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sarra Elamin, MD
role: Principal Investigator
affiliation: Consultant Nephrologist
last name: Sarra Elamin, MD
phone: (+249)912474666
email: sarraelamin@hotmail.com
last name: Nazar Zulfo, MD
phone: (+249)900948820
email: nazarzuflo@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Sudan
responsible party type: Principal Investigator
investigator affiliation: University of Khartoum
investigator full name: Sarra Elamin
investigator title: Consultant Physician and Nephrologist
mesh term: Interleukin-2
mesh term: Immunoglobulins
mesh term: Immunoglobulins, Intravenous
mesh term: Antibodies
mesh term: Basiliximab
mesh term: Thymoglobulin
mesh term: Antilymphocyte Serum
sharing ipd: Undecided