<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/NCT04414735</url>
  </required_header>
  <id_info>
    <org_study_id>HCB/2018/0853</org_study_id>
    <nct_id>NCT04414735</nct_id>
  </id_info>
  <brief_title>Impact of Photopheresis in the Prevention of Acute Rejection in Highly Sensitized de Novo Kidney Transplant Recipients</brief_title>
  <official_title>Impact of Photopheresis in the Prevention of Acute Rejection in Highly Sensitized de Novo Kidney Transplant Recipients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacion Clinic per a la Recerca Biomédica</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mallinckrodt</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundacion Clinic per a la Recerca Biomédica</source>
  <oversight_info>
    <has_dmc>No</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>
      The aim of the present study is to evaluate the superiority of photopheresis in combination&#xD;
      with the standard immunosuppression vs standard immunosuppression alone for the prevention of&#xD;
      acute rejection in highly sensitized kidney transplant recipients (cPRA ≥90%).&#xD;
&#xD;
      Unicentric, randomized, open study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 17, 2022</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">March 2025</primary_completion_date>
  <phase>N/A</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>Unicentric, randomized, open study.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to first histological rejection in the first year of kidney transplantation.</measure>
    <time_frame>1 year after kidney transplantation</time_frame>
    <description>Time to first histological rejection in the first year of kidney transplantation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biopsy proved acute rejection</measure>
    <time_frame>1 year after kidney transplantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glomerular filtrate rate at one year after kidney transplant</measure>
    <time_frame>1 year after kidney transplantation</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Kidney Transplant Rejection</condition>
  <arm_group>
    <arm_group_label>1- Control group (Standard immunosuppression)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>1- Control group (n=15): Standard immunosuppression (Thymoglobulin, Prednisone, Tacrolimus, and Everolimus or Mycophenolate), according to the clinical protocol of the Nephrology and Kidney Transplant Department.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2- Treatment group (ECP+Standard immunosuppression)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2- Treatment group (n=15): Extracorporeal photopheresis in combination with standard immunosuppression (Thymoglobulin, Prednisone, Tacrolimus, and Everolimus or Mycophenolate) according to the clinical protocol of the Nephrology and Kidney Transplant Department</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Extracorporeal Photopheresis</intervention_name>
    <description>Infusion of autologous cellular products exposed to ultraviolet light (UV), in the presence of a photosensitizer. The cellular product is obtained through leucopheresis and its subsequent exposure to 8-methoxypsoralen (8-MOP) and irradiation with UV-A light.</description>
    <arm_group_label>2- Treatment group (ECP+Standard immunosuppression)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sensitized (cPRA ≥90%) candidates for a deceased-donor kidney transplantation&#xD;
&#xD;
          -  Recipients between 18 and 75 years old&#xD;
&#xD;
          -  Patients are able to understand and sign informed consent (Annex 1).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in another interventional clinical trial.&#xD;
&#xD;
          -  Use of Rituximab or Eculizumab at the time of transplant or in the first 24 hours&#xD;
             post-transplant.&#xD;
&#xD;
          -  Persons with any dependency on the researcher or employee by the responsible&#xD;
             institution or researcher. As well as people detained by legal order.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Diekmann</last_name>
    <phone>+34932275400</phone>
    <phone_ext>5444</phone_ext>
    <email>fdiekman@clinic.cat</email>
  </overall_contact>
  <location>
    <facility>
      <name>Deparment of Nephology and Kidney Transplant</name>
      <address>
        <city>Barcelona</city>
        <state>Please Select</state>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gastón J Piñeiro, MD</last_name>
      <email>gjpineir@clinic.cat</email>
    </contact>
    <contact_backup>
      <last_name>Fritz Diekmann, MD, PhD</last_name>
      <phone>+34932275400</phone>
      <phone_ext>5444</phone_ext>
      <email>fdiekman@clinic.cat</email>
    </contact_backup>
    <investigator>
      <last_name>Gastón J Piñeiro, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Fritz Diekmann, MD,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jordi Rovira, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pedro Ventura, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Jaksch P, Knobler R. ECP and solid organ transplantation. Transfus Apher Sci. 2014 Jun;50(3):358-62. doi: 10.1016/j.transci.2014.04.006. Epub 2014 Apr 13.</citation>
    <PMID>24768429</PMID>
  </reference>
  <reference>
    <citation>Heshmati F. Updating ECP action mechanisms. Transfus Apher Sci. 2014 Jun;50(3):330-9. doi: 10.1016/j.transci.2014.04.003. Epub 2014 Apr 13.</citation>
    <PMID>24837416</PMID>
  </reference>
  <reference>
    <citation>Rose EA, Barr ML, Xu H, Pepino P, Murphy MP, McGovern MA, Ratner AJ, Watkins JF, Marboe CC, Berger CL. Photochemotherapy in human heart transplant recipients at high risk for fatal rejection. J Heart Lung Transplant. 1992 Jul-Aug;11(4 Pt 1):746-50.</citation>
    <PMID>1498142</PMID>
  </reference>
  <reference>
    <citation>Barr ML, Meiser BM, Eisen HJ, Roberts RF, Livi U, Dall'Amico R, Dorent R, Rogers JG, Radovancevic B, Taylor DO, Jeevanandam V, Marboe CC. Photopheresis for the prevention of rejection in cardiac transplantation. Photopheresis Transplantation Study Group. N Engl J Med. 1998 Dec 10;339(24):1744-51. doi: 10.1056/NEJM199812103392404.</citation>
    <PMID>9845709</PMID>
  </reference>
  <reference>
    <citation>Barr ML, Baker CJ, Schenkel FA, McLaughlin SN, Stouch BC, Starnes VA, Rose EA. Prophylactic photopheresis and chronic rejection: effects on graft intimal hyperplasia in cardiac transplantation. Clin Transplant. 2000 Apr;14(2):162-6. doi: 10.1034/j.1399-0012.2000.140211.x.</citation>
    <PMID>10770423</PMID>
  </reference>
  <reference>
    <citation>Kirklin JK, Brown RN, Huang ST, Naftel DC, Hubbard SM, Rayburn BK, McGiffin DC, Bourge RB, Benza RL, Tallaj JA, Pinderski LJ, Pamboukian SV, George JF, Marques M. Rejection with hemodynamic compromise: objective evidence for efficacy of photopheresis. J Heart Lung Transplant. 2006 Mar;25(3):283-8. doi: 10.1016/j.healun.2005.10.004. Epub 2006 Jan 25.</citation>
    <PMID>16507420</PMID>
  </reference>
  <reference>
    <citation>Pecoraro Y, Carillo C, Diso D, Mantovani S, Cimino G, De Giacomo T, Troiani P, Shafii M, Gherzi L, Amore D, Rendina EA, Venuta F, Anile M. Efficacy of Extracorporeal Photopheresis in Patients With Bronchiolitis Obliterans Syndrome After Lung Transplantation. Transplant Proc. 2017 May;49(4):695-698. doi: 10.1016/j.transproceed.2017.02.035.</citation>
    <PMID>28457374</PMID>
  </reference>
  <reference>
    <citation>Jaksch P, Scheed A, Keplinger M, Ernst MB, Dani T, Just U, Nahavandi H, Klepetko W, Knobler R. A prospective interventional study on the use of extracorporeal photopheresis in patients with bronchiolitis obliterans syndrome after lung transplantation. J Heart Lung Transplant. 2012 Sep;31(9):950-7. doi: 10.1016/j.healun.2012.05.002.</citation>
    <PMID>22884382</PMID>
  </reference>
  <reference>
    <citation>Kusztal M, Koscielska-Kasprzak K, Gdowska W, Zabinska M, Myszka M, Klak R, Krajewska M, Boratynska M, Szyber P, Chudoba P, Patrzalek D, Klinger M. Extracorporeal photopheresis as an antirejection prophylaxis in kidney transplant recipients: preliminary results. Transplant Proc. 2011 Oct;43(8):2938-40. doi: 10.1016/j.transproceed.2011.08.061.</citation>
    <PMID>21996194</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 30, 2020</study_first_submitted>
  <study_first_submitted_qc>May 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>July 4, 2023</last_update_submitted>
  <last_update_submitted_qc>July 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundacion Clinic per a la Recerca Biomédica</investigator_affiliation>
    <investigator_full_name>Fritz Diekmann</investigator_full_name>
    <investigator_title>Head of the Experimental Laboratory of Nephrology and Transplantation (LENIT)</investigator_title>
  </responsible_party>
  <keyword>Kidney Transplant Rejection</keyword>
  <keyword>photopheresis</keyword>
  <keyword>Antibody-mediated rejection</keyword>
  <keyword>Chronic active antibody-mediated rejection</keyword>
  <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/NCT04414735
org study id: HCB/2018/0853
nct id: NCT04414735
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the present study is to evaluate the superiority of photopheresis in combination
      with the standard immunosuppression vs standard immunosuppression alone for the prevention of
      acute rejection in highly sensitized kidney transplant recipients (cPRA ≥90%).

      Unicentric, randomized, open study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Unicentric, randomized, open study.
primary purpose: Prevention
masking: None (Open Label)
measure: Time to first histological rejection in the first year of kidney transplantation.
time frame: 1 year after kidney transplantation
description: Time to first histological rejection in the first year of kidney transplantation.
measure: Biopsy proved acute rejection
time frame: 1 year after kidney transplantation
measure: Glomerular filtrate rate at one year after kidney transplant
time frame: 1 year after kidney transplantation
arm group label: 1- Control group (Standard immunosuppression)
arm group type: No Intervention
description: 1- Control group (n=15): Standard immunosuppression (Thymoglobulin, Prednisone, Tacrolimus, and Everolimus or Mycophenolate), according to the clinical protocol of the Nephrology and Kidney Transplant Department.
arm group label: 2- Treatment group (ECP+Standard immunosuppression)
arm group type: Experimental
description: 2- Treatment group (n=15): Extracorporeal photopheresis in combination with standard immunosuppression (Thymoglobulin, Prednisone, Tacrolimus, and Everolimus or Mycophenolate) according to the clinical protocol of the Nephrology and Kidney Transplant Department
intervention type: Other
intervention name: Extracorporeal Photopheresis
description: Infusion of autologous cellular products exposed to ultraviolet light (UV), in the presence of a photosensitizer. The cellular product is obtained through leucopheresis and its subsequent exposure to 8-methoxypsoralen (8-MOP) and irradiation with UV-A light.
arm group label: 2- Treatment group (ECP+Standard immunosuppression)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Diekmann
phone: +34932275400
phone ext: 5444
email: fdiekman@clinic.cat
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Spain
citation: Jaksch P, Knobler R. ECP and solid organ transplantation. Transfus Apher Sci. 2014 Jun;50(3):358-62. doi: 10.1016/j.transci.2014.04.006. Epub 2014 Apr 13.
PMID: 24768429
citation: Heshmati F. Updating ECP action mechanisms. Transfus Apher Sci. 2014 Jun;50(3):330-9. doi: 10.1016/j.transci.2014.04.003. Epub 2014 Apr 13.
PMID: 24837416
citation: Rose EA, Barr ML, Xu H, Pepino P, Murphy MP, McGovern MA, Ratner AJ, Watkins JF, Marboe CC, Berger CL. Photochemotherapy in human heart transplant recipients at high risk for fatal rejection. J Heart Lung Transplant. 1992 Jul-Aug;11(4 Pt 1):746-50.
PMID: 1498142
citation: Barr ML, Meiser BM, Eisen HJ, Roberts RF, Livi U, Dall'Amico R, Dorent R, Rogers JG, Radovancevic B, Taylor DO, Jeevanandam V, Marboe CC. Photopheresis for the prevention of rejection in cardiac transplantation. Photopheresis Transplantation Study Group. N Engl J Med. 1998 Dec 10;339(24):1744-51. doi: 10.1056/NEJM199812103392404.
PMID: 9845709
citation: Barr ML, Baker CJ, Schenkel FA, McLaughlin SN, Stouch BC, Starnes VA, Rose EA. Prophylactic photopheresis and chronic rejection: effects on graft intimal hyperplasia in cardiac transplantation. Clin Transplant. 2000 Apr;14(2):162-6. doi: 10.1034/j.1399-0012.2000.140211.x.
PMID: 10770423
citation: Kirklin JK, Brown RN, Huang ST, Naftel DC, Hubbard SM, Rayburn BK, McGiffin DC, Bourge RB, Benza RL, Tallaj JA, Pinderski LJ, Pamboukian SV, George JF, Marques M. Rejection with hemodynamic compromise: objective evidence for efficacy of photopheresis. J Heart Lung Transplant. 2006 Mar;25(3):283-8. doi: 10.1016/j.healun.2005.10.004. Epub 2006 Jan 25.
PMID: 16507420
citation: Pecoraro Y, Carillo C, Diso D, Mantovani S, Cimino G, De Giacomo T, Troiani P, Shafii M, Gherzi L, Amore D, Rendina EA, Venuta F, Anile M. Efficacy of Extracorporeal Photopheresis in Patients With Bronchiolitis Obliterans Syndrome After Lung Transplantation. Transplant Proc. 2017 May;49(4):695-698. doi: 10.1016/j.transproceed.2017.02.035.
PMID: 28457374
citation: Jaksch P, Scheed A, Keplinger M, Ernst MB, Dani T, Just U, Nahavandi H, Klepetko W, Knobler R. A prospective interventional study on the use of extracorporeal photopheresis in patients with bronchiolitis obliterans syndrome after lung transplantation. J Heart Lung Transplant. 2012 Sep;31(9):950-7. doi: 10.1016/j.healun.2012.05.002.
PMID: 22884382
citation: Kusztal M, Koscielska-Kasprzak K, Gdowska W, Zabinska M, Myszka M, Klak R, Krajewska M, Boratynska M, Szyber P, Chudoba P, Patrzalek D, Klinger M. Extracorporeal photopheresis as an antirejection prophylaxis in kidney transplant recipients: preliminary results. Transplant Proc. 2011 Oct;43(8):2938-40. doi: 10.1016/j.transproceed.2011.08.061.
PMID: 21996194
responsible party type: Principal Investigator
investigator affiliation: Fundacion Clinic per a la Recerca Biomédica
investigator full name: Fritz Diekmann
investigator title: Head of the Experimental Laboratory of Nephrology and Transplantation (LENIT)
sharing ipd: No