<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/NCT03828682</url>
  </required_header>
  <id_info>
    <org_study_id>2018-7742</org_study_id>
    <nct_id>NCT03828682</nct_id>
  </id_info>
  <brief_title>Veloxis de Novo Kidney Transplant ECSWD</brief_title>
  <official_title>A 12-Month, Open Label Study of Extended Release Tacrolimus (Envarsus XR®, LCPT) With Mycophenolate, Rabbit Antithymocyte Globulin (rATG) and Early Steroid Withdrawal in de Novo Kidney Transplant Recipients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Simon Tremblay, PharmD, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Veloxis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Cincinnati</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to evaluate the safety and efficacy of LCPT in combination with rATG,&#xD;
      mycophenolate and early corticosteroid withdrawal (CSWD) in de novo kidney transplant&#xD;
      recipients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 21, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>A prospective cohort of de novo kidney transplant recipients will be assigned to treatment group and compared to historical controls</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients with the combination oral outcome of Biopsy-proven acute rejection, patient death and graft loss</measure>
    <time_frame>12 months</time_frame>
    <description>Biopsy-proven acute rejection, patient death and graft loss</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Kidney Transplantation</condition>
  <condition>Immunosuppression</condition>
  <arm_group>
    <arm_group_label>Prospective Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>De novo kidney transplant recipients receiving:&#xD;
rabbit antithymocyte globulin induction (1.5mg/kg, dosage range 4-6mg/kg total dose over 5-10 days) 5-day steroid withdrawal (methylprednisolone 500mg IV on day 1 (day of transplant), 250mg IV on day 2, 125mg IV on day 3, prednisone 80mg PO on day 4, 60mg PO on day 5 and then no more steroids Once-daily tacrolimus XR 0.8mg/kg/day started when or when serum creatinine is &lt;4mg/dL or by 48 hours of transplant to target 24-hr trough levels of 8-12ng/mL up to day 30 followed by 24-hour trough targets of 5-10ng/mL Mycophenolate mofetil (1000 mg PO BID) or mycophenolic acid (720mg PO BID) twice daily started prior to surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Historical control arm consisting of the following&#xD;
De novo kidney transplant recipients receiving:&#xD;
rabbit antithymocyte globulin induction (1.5mg/kg, dosage range 4-6mg/kg total dose over 5-10 days) 5-day steroid withdrawal (methylprednisolone 500mg IV on day 1 (day of transplant), 250mg IV on day 2, 125mg IV on day 3, prednisone 80mg PO on day 4, 60mg PO on day 5 and then no more steroids Twice-daily tacrolimus 0.1mg/kg/day started when or when serum creatinine is &lt;4mg/dL or by 48 hours of transplant to target 12-hr trough levels of 8-12ng/mL up to day 30 followed by 12-hour trough targets of 5-10ng/mL Mycophenolate mofetil (1000 mg PO BID) or mycophenolic acid (720mg PO BID) twice daily started prior to surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tacrolimus Extended Release Oral Tablet [Envarsus]</intervention_name>
    <description>Tacrolimus Extended Release Oral Tablet [Envarsus]</description>
    <arm_group_label>Prospective Arm</arm_group_label>
    <other_name>Envarsus XR</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mycophenolate Mofetil</intervention_name>
    <description>Mycophenolate mofetil capsules or tablets</description>
    <arm_group_label>Comparator arm</arm_group_label>
    <arm_group_label>Prospective Arm</arm_group_label>
    <other_name>Cellcept</other_name>
    <other_name>MMF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mycophenolic Acid Oral Product</intervention_name>
    <description>mycophenolic acid tablets</description>
    <arm_group_label>Comparator arm</arm_group_label>
    <arm_group_label>Prospective Arm</arm_group_label>
    <other_name>Myfortic</other_name>
    <other_name>MPA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tacrolimus</intervention_name>
    <description>Twice daily tacrolimus</description>
    <arm_group_label>Comparator arm</arm_group_label>
    <other_name>Prograf</other_name>
    <other_name>FK506</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methylprednisolone</intervention_name>
    <description>Methylprednisolone taper</description>
    <arm_group_label>Comparator arm</arm_group_label>
    <arm_group_label>Prospective Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>Prednisone taper</description>
    <arm_group_label>Comparator arm</arm_group_label>
    <arm_group_label>Prospective Arm</arm_group_label>
    <other_name>Deltasone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin]</intervention_name>
    <description>Rabbit Anti-Human T-Lymphocyte Globulin</description>
    <arm_group_label>Comparator arm</arm_group_label>
    <arm_group_label>Prospective Arm</arm_group_label>
    <other_name>Thymoglobulin</other_name>
    <other_name>rATG</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female patients ≥ 18 years of age.&#xD;
&#xD;
          2. Patient who is receiving a renal transplant from a living or heart-beating deceased&#xD;
             donor.&#xD;
&#xD;
          3. Female patients of child bearing potential must have a negative urine or serum&#xD;
             pregnancy test within the past 48 hours prior to study inclusion.&#xD;
&#xD;
          4. The patient has given written informed consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient has previously received an organ transplant other than a kidney.&#xD;
&#xD;
          2. Patient is receiving an HLA identical living donor transplant.&#xD;
&#xD;
          3. Patient who is a recipient of a multiple organ transplant.&#xD;
&#xD;
          4. Patient has a most recent cytotoxic PRA of &gt;25% or calculated PRA &gt;50% where multiple&#xD;
             moderate level HLA antibodies exist and in the opinion of the PI represents&#xD;
             substantial HLA sensitization.&#xD;
&#xD;
          5. Patient with a positive T or B cell crossmatch that is primarily due to HLA&#xD;
             antibodies.&#xD;
&#xD;
          6. Patient with a donor specific antibody (DSA) as deemed by the PI to be associated with&#xD;
             significant risk of rejection.&#xD;
&#xD;
          7. Patient has received an ABO incompatible donor kidney.&#xD;
&#xD;
          8. The deceased donor and/or deceased donor kidney meet any of the following extended&#xD;
             criteria for organ donation (ECD):&#xD;
&#xD;
               1. Donor age ≥ 60 years OR&#xD;
&#xD;
               2. Donor age 50-59 years and 1 of the following:&#xD;
&#xD;
             i. Cerebrovascular accident (CVA) + hypertension + SCr &gt; 1.5 mg/dL OR ii. CVA +&#xD;
             hypertension OR iii. CVA + SCr &gt; 1.5 mg/dL OR iv. Hypertension + SCr &gt; 1.5 mg/dL OR c.&#xD;
             CIT ≥ 24 hours, donor age &gt; 10 years OR d. Donation after cardiac death (DCD)&#xD;
&#xD;
          9. Recipients will be receiving a dual or en bloc kidney transplant.&#xD;
&#xD;
         10. Donor anticipated cold ischemia is &gt;30hours.&#xD;
&#xD;
         11. Recipient that is seropositive for hepatitis C virus (HCV) with detectable Hepatitis C&#xD;
             viral load are excluded. HCV seropositive patients with a negative HCV viral load&#xD;
             testing may be included.&#xD;
&#xD;
         12. Recipients with a positive hepatitis B viral load or positive hepatitis B surface&#xD;
             antigen testing within 1 year of consent.&#xD;
&#xD;
         13. Hepatitis B surface antibody negative recipients receiving a kidney from a donor&#xD;
             seropositive for hepatitis B core antibody or hepatitis B nucleic acid.&#xD;
&#xD;
         14. Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).&#xD;
&#xD;
         15. Recipient who is seronegative for Epstein Barr Virus (EBV)&#xD;
&#xD;
         16. Patient has uncontrolled concomitant infection or any other unstable medical condition&#xD;
             that could interfere with the study objectives.&#xD;
&#xD;
         17. Patients with thrombocytopenia (PLT &lt;75,000/mm3), and/or leukopenia (WBC &lt; 2,000/mm3),&#xD;
             or anemia (hemoglobin &lt; 6 g/dL) prior to study inclusion.&#xD;
&#xD;
         18. Patient is taking or has been taking an investigational drug in the 30 days prior to&#xD;
             transplant.&#xD;
&#xD;
         19. Patient who has undergone desensitization therapy within 6 months prior to transplant.&#xD;
&#xD;
         20. Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil/mycophenolic&#xD;
             acid, rabbit anti-thymocyte globulin, or glucocorticoids.&#xD;
&#xD;
         21. Patient is receiving chronic steroid therapy at the time of transplant.&#xD;
&#xD;
         22. Patients with a history of cancer (other than non-melanoma skin cell cancers cured by&#xD;
             local resection) within the last 5 years, unless they have an expected disease free&#xD;
             survival of &gt;95%.&#xD;
&#xD;
         23. Patient is pregnant, where pregnancy is defined as the state of a female after&#xD;
             conception and until the termination of gestation, confirmed by positive human&#xD;
             Chorionic Gonadotropin (hCG) laboratory test.&#xD;
&#xD;
         24. Women of childbearing potential must use reliable contraception simultaneously, unless&#xD;
             they are status post bilateral tubal ligation, bilateral oophorectomy, or&#xD;
             hysterectomy.&#xD;
&#xD;
         25. Patient has any form of substance abuse, psychiatric disorder or a condition that, in&#xD;
             the opinion of the investigator, may invalidate communication with the investigator.&#xD;
&#xD;
         26. Inability to cooperate or communicate with the investigator.&#xD;
&#xD;
         27. Renal allograft has been reperfused for more than 48 hours at the time of enrollment&#xD;
&#xD;
         28. Patient unable to receive intact LCPT formulation&#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>Simon Tremblay, PharmD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cincinnati</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Simon Tremblay, PharmD, PhD</last_name>
    <phone>513-558-9967</phone>
    <email>tremblsn@ucmail.uc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Christ Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Simon Tremblay, PharmD, PhD</last_name>
      <phone>513-558-9967</phone>
      <email>simon.tremblay@uc.edu</email>
    </contact>
    <investigator>
      <last_name>Adele Rike-Shields, PharmD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ervin S Woodle, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Simon Tremblay, PharmD, PhD</last_name>
      <phone>513-558-9967</phone>
      <email>simon.tremblay@uc.edu</email>
    </contact>
    <investigator>
      <last_name>Rita R Alloway, PharmD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ervin S Woodle, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Amit Govil, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>May 12, 2020</last_update_submitted>
  <last_update_submitted_qc>May 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Cincinnati</investigator_affiliation>
    <investigator_full_name>Simon Tremblay, PharmD, PhD</investigator_full_name>
    <investigator_title>Research Assistant Professor of Surgery</investigator_title>
  </responsible_party>
  <keyword>tacrolimus</keyword>
  <keyword>extended release</keyword>
  <keyword>kidney transplantation</keyword>
  <keyword>steroid withdrawal</keyword>
  <keyword>once daily</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mycophenolic Acid</mesh_term>
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Methylprednisolone</mesh_term>
    <mesh_term>Tacrolimus</mesh_term>
    <mesh_term>Thymoglobulin</mesh_term>
    <mesh_term>Antilymphocyte Serum</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/NCT03828682
org study id: 2018-7742
nct id: NCT03828682
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This study is designed to evaluate the safety and efficacy of LCPT in combination with rATG,
      mycophenolate and early corticosteroid withdrawal (CSWD) in de novo kidney transplant
      recipients.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A prospective cohort of de novo kidney transplant recipients will be assigned to treatment group and compared to historical controls
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of patients with the combination oral outcome of Biopsy-proven acute rejection, patient death and graft loss
time frame: 12 months
description: Biopsy-proven acute rejection, patient death and graft loss
arm group label: Prospective Arm
arm group type: Experimental
description: De novo kidney transplant recipients receiving:
rabbit antithymocyte globulin induction (1.5mg/kg, dosage range 4-6mg/kg total dose over 5-10 days) 5-day steroid withdrawal (methylprednisolone 500mg IV on day 1 (day of transplant), 250mg IV on day 2, 125mg IV on day 3, prednisone 80mg PO on day 4, 60mg PO on day 5 and then no more steroids Once-daily tacrolimus XR 0.8mg/kg/day started when or when serum creatinine is <4mg/dL or by 48 hours of transplant to target 24-hr trough levels of 8-12ng/mL up to day 30 followed by 24-hour trough targets of 5-10ng/mL Mycophenolate mofetil (1000 mg PO BID) or mycophenolic acid (720mg PO BID) twice daily started prior to surgery
arm group label: Comparator arm
arm group type: Active Comparator
description: Historical control arm consisting of the following
De novo kidney transplant recipients receiving:
rabbit antithymocyte globulin induction (1.5mg/kg, dosage range 4-6mg/kg total dose over 5-10 days) 5-day steroid withdrawal (methylprednisolone 500mg IV on day 1 (day of transplant), 250mg IV on day 2, 125mg IV on day 3, prednisone 80mg PO on day 4, 60mg PO on day 5 and then no more steroids Twice-daily tacrolimus 0.1mg/kg/day started when or when serum creatinine is <4mg/dL or by 48 hours of transplant to target 12-hr trough levels of 8-12ng/mL up to day 30 followed by 12-hour trough targets of 5-10ng/mL Mycophenolate mofetil (1000 mg PO BID) or mycophenolic acid (720mg PO BID) twice daily started prior to surgery
intervention type: Drug
intervention name: Tacrolimus Extended Release Oral Tablet [Envarsus]
description: Tacrolimus Extended Release Oral Tablet [Envarsus]
arm group label: Prospective Arm
other name: Envarsus XR
intervention type: Drug
intervention name: Mycophenolate Mofetil
description: Mycophenolate mofetil capsules or tablets
arm group label: Comparator arm
arm group label: Prospective Arm
other name: Cellcept
other name: MMF
intervention type: Drug
intervention name: Mycophenolic Acid Oral Product
description: mycophenolic acid tablets
arm group label: Comparator arm
arm group label: Prospective Arm
other name: Myfortic
other name: MPA
intervention type: Drug
intervention name: Tacrolimus
description: Twice daily tacrolimus
arm group label: Comparator arm
other name: Prograf
other name: FK506
intervention type: Drug
intervention name: Methylprednisolone
description: Methylprednisolone taper
arm group label: Comparator arm
arm group label: Prospective Arm
intervention type: Drug
intervention name: Prednisone
description: Prednisone taper
arm group label: Comparator arm
arm group label: Prospective Arm
other name: Deltasone
intervention type: Drug
intervention name: Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin]
description: Rabbit Anti-Human T-Lymphocyte Globulin
arm group label: Comparator arm
arm group label: Prospective Arm
other name: Thymoglobulin
other name: rATG
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Simon Tremblay, PharmD, PhD
role: Principal Investigator
affiliation: University of Cincinnati
last name: Simon Tremblay, PharmD, PhD
phone: 513-558-9967
email: tremblsn@ucmail.uc.edu
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Cincinnati
investigator full name: Simon Tremblay, PharmD, PhD
investigator title: Research Assistant Professor of Surgery
mesh term: Mycophenolic Acid
mesh term: Prednisone
mesh term: Methylprednisolone
mesh term: Tacrolimus
mesh term: Thymoglobulin
mesh term: Antilymphocyte Serum
sharing ipd: No