<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/NCT03006419</url>
  </required_header>
  <id_info>
    <org_study_id>R-2016-3001-61</org_study_id>
    <nct_id>NCT03006419</nct_id>
  </id_info>
  <brief_title>Basiliximab vs Low-dose Thymoglobulin Induction Therapy in Low Risk Kidney Transplant Patients</brief_title>
  <official_title>Basiliximab vs Reduced Dose Rabbit Antithymocyte Globulin (rRTAG): Evaluation of Efficacy and Safety Outcomes in Low Immunological Risk Living Donor Kidney Transplant: 12-month Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coordinación de Investigación en Salud, Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Coordinación de Investigación en Salud, Mexico</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Demonstrate that low dose (3 mg/kg total ) rATG (thymoglobulin) has similar efficacy (delayed&#xD;
      graft function, slow graft function, biopsy proven acute rejection episodes, infections,&#xD;
      hospitalizations, adverse events, graft loss and death) than Basiliximab induction&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: The TAILOR study in living donor kidney transplantation demonstrated a 98% one&#xD;
      year patient and graft survival and 91% and 83% at 5 years with rejection-free patients in&#xD;
      93%. The cumulative dose of r ATG (thymoglobulin) was 5.29 mg / kg with 3% adverse effects&#xD;
      and almost 50% steroid free at 12 months. Others have explored the benefit of low doses of r&#xD;
      ATG (thymoglobulin) (3-5 mg / kg) against Basiliximab in low-risk population and demonstrated&#xD;
      in living donor recipients with 8 year follow-up similar survival rates with a lower BPAR&#xD;
      rate in rATG (thymoglobulin) (p &lt;0.05) and better serum creatinine in 3 and 5 years. The aim&#xD;
      of the study was to demonstrate that low dose (3 mg/kg total ) rATG (thymoglobulin) has&#xD;
      similar efficacy (delayed graft function, slow graft function, biopsy proven acute rejection&#xD;
      episodes, infections, hospitalizations, adverse events, graft loss and death) than&#xD;
      Basiliximab induction.&#xD;
&#xD;
      Material and methods: Prospective randomized study of patients undergoing renal&#xD;
      transplantation who wish to participate. 100 patients who meet the inclusion and exclusion&#xD;
      criteria at the time of transplantation will be randomized&#xD;
&#xD;
      Experimental and reference therapy:&#xD;
&#xD;
      Group A: Induction with Basiliximab 20 mg IV day 0 and day 4 Group B: rATG (Thymoglobulin) 1&#xD;
      mg / kg body weight per day for days 0, 1 and 2 up to a total dose of 3 mg / kg day.&#xD;
      According to protocol administration, if there are conditions to delay administration&#xD;
      (WBC&lt;2000 / mm3 and / or platelets &lt;75,000 / mm3) (17), administration may be postponed until&#xD;
      day 7 posttransplant Posttransplant immunosuppression: Tacrolimus, mycophenolate mofetil and&#xD;
      steroids&#xD;
&#xD;
      Outcome measures (12 months) delayed graft function slow graft function biopsy proven acute&#xD;
      rejection episodes infections hospitalizations adverse events graft loss death&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Actual">July 30, 2019</completion_date>
  <primary_completion_date type="Actual">July 30, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Biopsy proven acute rejection</measure>
    <time_frame>12 months following transplantation</time_frame>
    <description>Acute rejection described by Banff category</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Delayed graft function</measure>
    <time_frame>12 months following transplantation</time_frame>
    <description>Dialysis during first week of transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Slow graft function</measure>
    <time_frame>12 months following transplantation</time_frame>
    <description>Creatinine clearance &lt; 50% pretransplant during first week of transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infections</measure>
    <time_frame>12 months following transplantation</time_frame>
    <description>Presence of a positive culture of any microorganism in presence of clinical symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital admissions</measure>
    <time_frame>12 months following transplantation</time_frame>
    <description>Admission to the hospital for at least 24 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Graft function</measure>
    <time_frame>12 months following transplantation</time_frame>
    <description>Creatinine clearance measured by MDRD-4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Graft loss</measure>
    <time_frame>12 months following transplantation</time_frame>
    <description>Return to dialysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient survival</measure>
    <time_frame>12 months following transplantation</time_frame>
    <description>Patient Death</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Kidney Transplant Rejection</condition>
  <condition>Kidney Transplant; Complications</condition>
  <arm_group>
    <arm_group_label>Group A (Basiliximab group)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Basiliximab (Simulect) induction therapy: 20 mg IV at day of transplant (to be administered 2 hours prior to transplant and up to 4 hours after transplant) and second dosage (20 mg) at fourth day after kidney transplantation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B (Low-dose Thymoglobulin group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thymoglobulin induction therapy (1 mg/kg rounded by 25 mg increments) at day of transplant followed by same dosage (1 mg/kg rounded by 25 mg increments) during day 1 and day 2 after transplant in order to complete 3 mg/kg accumulated dose.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Basiliximab</intervention_name>
    <description>Standard induction therapy</description>
    <arm_group_label>Group A (Basiliximab group)</arm_group_label>
    <other_name>Simulect</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Thymoglobulin</intervention_name>
    <description>Induction therapy</description>
    <arm_group_label>B (Low-dose Thymoglobulin group)</arm_group_label>
    <other_name>rATG</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female graft recipients older than 18 years of age.&#xD;
&#xD;
          -  Informed consent to participate in the study.&#xD;
&#xD;
          -  First living donor kidney transplant recipient.&#xD;
&#xD;
          -  Negative pregnancy test if female participant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Second or more kidney transplant.&#xD;
&#xD;
          -  Multiple organ transplant recipients.&#xD;
&#xD;
          -  ABO incompatibility or positive cross-over test prior to transplantation.&#xD;
&#xD;
          -  Antibody Reactive Panel (PRA) &gt; 30%.&#xD;
&#xD;
          -  Positive specific donor antibodies (DSA).&#xD;
&#xD;
          -  Human immunodeficiency virus (HIV) positive patients.&#xD;
&#xD;
          -  HBsAg or HCV positive.&#xD;
&#xD;
          -  Severe lung disorders.&#xD;
&#xD;
          -  Severe allergies receiving treatment that prevent patient's rRTAG administration.&#xD;
&#xD;
          -  Leukocyte count below 2000 / mm3.&#xD;
&#xD;
          -  Platelet count below 75,000 / mm3.&#xD;
&#xD;
          -  History of malignant disease of any organ system (except skin basal cell carcinoma)&#xD;
             within the last 5 years, regardless of local recurrence or metastasis.&#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>Gustavo Martinez-Mier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jefe de División, UMAE 189, Veracruz, Veracruz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Umae Hospital Especialidades 14 Adolfo Ruiz Cortines</name>
      <address>
        <city>Veracruz</city>
        <zip>91897</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <reference>
    <citation>Laftavi MR, Alnimri M, Weber-Shrikant E, Kohli R, Said M, Patel S, Pankewycz O. Low-dose rabbit antithymocyte globulin versus basiliximab induction therapy in low-risk renal transplant recipients: 8-year follow-up. Transplant Proc. 2011 Mar;43(2):458-61. doi: 10.1016/j.transproceed.2011.01.035.</citation>
    <PMID>21440733</PMID>
  </reference>
  <reference>
    <citation>Schenker P, Ozturk A, Vonend O, Kruger B, Jazra M, Wunsch A, Kramer B, Viebahn R. Single-dose thymoglobulin induction in living-donor renal transplantation. Ann Transplant. 2011 Apr-Jun;16(2):50-8. doi: 10.12659/aot.881865.</citation>
    <PMID>21716186</PMID>
  </reference>
  <results_reference>
    <citation>Brennan DC, Daller JA, Lake KD, Cibrik D, Del Castillo D; Thymoglobulin Induction Study Group. Rabbit antithymocyte globulin versus basiliximab in renal transplantation. N Engl J Med. 2006 Nov 9;355(19):1967-77. doi: 10.1056/NEJMoa060068.</citation>
    <PMID>17093248</PMID>
  </results_reference>
  <results_reference>
    <citation>Gaber AO, Matas AJ, Henry ML, Brennan DC, Stevens RB, Kapur S, Ilsley JN, Kistler KD, Cosimi AB; Thymoglobulin Antibody Immunosuppression in Living Donor Recipients Investigators. Antithymocyte globulin induction in living donor renal transplant recipients: final report of the TAILOR registry. Transplantation. 2012 Aug 27;94(4):331-7. doi: 10.1097/TP.0b013e31825a7d1f.</citation>
    <PMID>22850297</PMID>
  </results_reference>
  <results_reference>
    <citation>Hardinger KL, Schnitzler MA, Koch MJ, Labile E, Stirnemann PM, Miller B, Enkvetchakul D, Brennan DC. Thymoglobulin induction is safe and effective in live-donor renal transplantation: a single center experience. Transplantation. 2006 May 15;81(9):1285-9. doi: 10.1097/01.tp.0000209825.91632.ea.</citation>
    <PMID>16699456</PMID>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>November 14, 2019</last_update_submitted>
  <last_update_submitted_qc>November 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>kidney transplantation</keyword>
  <keyword>induction</keyword>
  <keyword>thymoglobulin</keyword>
  <keyword>basiliximab</keyword>
  <keyword>acute rejection</keyword>
  <keyword>graft loss</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thymoglobulin</mesh_term>
    <mesh_term>Basiliximab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No IPD sharing plan</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>August 12, 2020</submitted>
    <returned>August 26, 2020</returned>
    <submitted>September 11, 2020</submitted>
    <returned>October 2, 2020</returned>
    <submitted>July 21, 2022</submitted>
    <returned>May 17, 2023</returned>
  </pending_results>
  <!-- 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/NCT03006419
org study id: R-2016-3001-61
nct id: NCT03006419
lead sponsor: 
has dmc: Yes
Demonstrate that low dose (3 mg/kg total ) rATG (thymoglobulin) has similar efficacy (delayed
      graft function, slow graft function, biopsy proven acute rejection episodes, infections,
      hospitalizations, adverse events, graft loss and death) than Basiliximab induction
Introduction: The TAILOR study in living donor kidney transplantation demonstrated a 98% one
      year patient and graft survival and 91% and 83% at 5 years with rejection-free patients in
      93%. The cumulative dose of r ATG (thymoglobulin) was 5.29 mg / kg with 3% adverse effects
      and almost 50% steroid free at 12 months. Others have explored the benefit of low doses of r
      ATG (thymoglobulin) (3-5 mg / kg) against Basiliximab in low-risk population and demonstrated
      in living donor recipients with 8 year follow-up similar survival rates with a lower BPAR
      rate in rATG (thymoglobulin) (p <0.05) and better serum creatinine in 3 and 5 years. The aim
      of the study was to demonstrate that low dose (3 mg/kg total ) rATG (thymoglobulin) has
      similar efficacy (delayed graft function, slow graft function, biopsy proven acute rejection
      episodes, infections, hospitalizations, adverse events, graft loss and death) than
      Basiliximab induction.

      Material and methods: Prospective randomized study of patients undergoing renal
      transplantation who wish to participate. 100 patients who meet the inclusion and exclusion
      criteria at the time of transplantation will be randomized

      Experimental and reference therapy:

      Group A: Induction with Basiliximab 20 mg IV day 0 and day 4 Group B: rATG (Thymoglobulin) 1
      mg / kg body weight per day for days 0, 1 and 2 up to a total dose of 3 mg / kg day.
      According to protocol administration, if there are conditions to delay administration
      (WBC<2000 / mm3 and / or platelets <75,000 / mm3) (17), administration may be postponed until
      day 7 posttransplant Posttransplant immunosuppression: Tacrolimus, mycophenolate mofetil and
      steroids

      Outcome measures (12 months) delayed graft function slow graft function biopsy proven acute
      rejection episodes infections hospitalizations adverse events graft loss death
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Biopsy proven acute rejection
time frame: 12 months following transplantation
description: Acute rejection described by Banff category
measure: Delayed graft function
time frame: 12 months following transplantation
description: Dialysis during first week of transplantation
measure: Slow graft function
time frame: 12 months following transplantation
description: Creatinine clearance < 50% pretransplant during first week of transplantation
measure: Infections
time frame: 12 months following transplantation
description: Presence of a positive culture of any microorganism in presence of clinical symptoms
measure: Hospital admissions
time frame: 12 months following transplantation
description: Admission to the hospital for at least 24 hours
measure: Graft function
time frame: 12 months following transplantation
description: Creatinine clearance measured by MDRD-4
measure: Graft loss
time frame: 12 months following transplantation
description: Return to dialysis
measure: Patient survival
time frame: 12 months following transplantation
description: Patient Death
arm group label: Group A (Basiliximab group)
arm group type: Active Comparator
description: Basiliximab (Simulect) induction therapy: 20 mg IV at day of transplant (to be administered 2 hours prior to transplant and up to 4 hours after transplant) and second dosage (20 mg) at fourth day after kidney transplantation.
arm group label: B (Low-dose Thymoglobulin group)
arm group type: Experimental
description: Thymoglobulin induction therapy (1 mg/kg rounded by 25 mg increments) at day of transplant followed by same dosage (1 mg/kg rounded by 25 mg increments) during day 1 and day 2 after transplant in order to complete 3 mg/kg accumulated dose.
intervention type: Drug
intervention name: Basiliximab
description: Standard induction therapy
arm group label: Group A (Basiliximab group)
other name: Simulect
intervention type: Drug
intervention name: Thymoglobulin
description: Induction therapy
arm group label: B (Low-dose Thymoglobulin group)
other name: rATG
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gustavo Martinez-Mier, MD
role: Principal Investigator
affiliation: Jefe de División, UMAE 189, Veracruz, Veracruz
facility: 
country: Mexico
citation: Laftavi MR, Alnimri M, Weber-Shrikant E, Kohli R, Said M, Patel S, Pankewycz O. Low-dose rabbit antithymocyte globulin versus basiliximab induction therapy in low-risk renal transplant recipients: 8-year follow-up. Transplant Proc. 2011 Mar;43(2):458-61. doi: 10.1016/j.transproceed.2011.01.035.
PMID: 21440733
citation: Schenker P, Ozturk A, Vonend O, Kruger B, Jazra M, Wunsch A, Kramer B, Viebahn R. Single-dose thymoglobulin induction in living-donor renal transplantation. Ann Transplant. 2011 Apr-Jun;16(2):50-8. doi: 10.12659/aot.881865.
PMID: 21716186
citation: Brennan DC, Daller JA, Lake KD, Cibrik D, Del Castillo D; Thymoglobulin Induction Study Group. Rabbit antithymocyte globulin versus basiliximab in renal transplantation. N Engl J Med. 2006 Nov 9;355(19):1967-77. doi: 10.1056/NEJMoa060068.
PMID: 17093248
citation: Gaber AO, Matas AJ, Henry ML, Brennan DC, Stevens RB, Kapur S, Ilsley JN, Kistler KD, Cosimi AB; Thymoglobulin Antibody Immunosuppression in Living Donor Recipients Investigators. Antithymocyte globulin induction in living donor renal transplant recipients: final report of the TAILOR registry. Transplantation. 2012 Aug 27;94(4):331-7. doi: 10.1097/TP.0b013e31825a7d1f.
PMID: 22850297
citation: Hardinger KL, Schnitzler MA, Koch MJ, Labile E, Stirnemann PM, Miller B, Enkvetchakul D, Brennan DC. Thymoglobulin induction is safe and effective in live-donor renal transplantation: a single center experience. Transplantation. 2006 May 15;81(9):1285-9. doi: 10.1097/01.tp.0000209825.91632.ea.
PMID: 16699456
responsible party type: Sponsor
mesh term: Thymoglobulin
mesh term: Basiliximab
sharing ipd: No
ipd description: No IPD sharing plan
submitted: August 12, 2020
returned: August 26, 2020
submitted: September 11, 2020
returned: October 2, 2020
submitted: July 21, 2022
returned: May 17, 2023