<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/NCT03773211</url>
  </required_header>
  <id_info>
    <org_study_id>RENAPAIR 01</org_study_id>
    <nct_id>NCT03773211</nct_id>
  </id_info>
  <brief_title>Renaparin® in Kidney Transplantation</brief_title>
  <official_title>Phase I Double Blind Placebo Controlled Safety Study of ex Vivo Treatment of Kidneys From Deceased Donors With Renaparin®, Followed by Transplantation to Study Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corline Biomedical AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Corline Biomedical AB</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>
      This study evaluates the safety and tolerability of Renaparin in adult patients receiving a&#xD;
      deceased donor kidney treated ex-vivo with Renaparin prior to transplantation. Half the&#xD;
      patient group will receive a kidney treated with Renaparin, while the other half of the&#xD;
      patient group will receive a kidney treated with placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Kidney transplantation is the last resort for end-stage renal disease (ESRD). A key problem&#xD;
      after transplantation is Delayed Graft Function (DGF). Short term, DGF will result in&#xD;
      patients being put on dialysis in the immediate time-period after transplantation. In the&#xD;
      longer perspective DGF is associated with increased risk of graft failure, thus decreasing&#xD;
      the efficacy of the kidney transplantation.&#xD;
&#xD;
      Renaparin is a new product under development for the prevention of DGF in association with&#xD;
      kidney transplantation. The product binds to the kidney vascular endothelium and its&#xD;
      pharmacological effect is based on a local and effective presentation of heparin. Renaparin&#xD;
      is administered ex vivo to the kidney by adding it to the preservation solution during&#xD;
      Hypothermic Machine Perfusion (HMP) prior to transplantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 14, 2019</start_date>
  <completion_date type="Actual">April 21, 2020</completion_date>
  <primary_completion_date type="Actual">April 21, 2020</primary_completion_date>
  <phase>Phase 1</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>30 days</time_frame>
    <description>Number and severity grade of Serious Adverse Events and Adverse Events including description of their associated MedDRA terms during the first 30 days after transplantation.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Delayed Graft Function</condition>
  <arm_group>
    <arm_group_label>Renaparin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Solution administered once to kidney ex-vivo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered once to kidney ex-vivo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Renaparin</intervention_name>
    <description>50 mL added at one occasion ex-vivo to machine perfusion solution to treat kidney at least 3 hours prior to transplantation</description>
    <arm_group_label>Renaparin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>50 mL added at one occasion ex-vivo to machine perfusion solution to treat kidney at least 3 hours prior to transplantation</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Organs:&#xD;
&#xD;
          -  Kidney must come from a deceased donor above 18 years of age&#xD;
&#xD;
          -  The regular protocols for organ donation according to Swedish law can be followed&#xD;
&#xD;
        Patients:&#xD;
&#xD;
          -  Male and female patients 18 - 75 years of age.&#xD;
&#xD;
          -  Ability to provide written informed consent.&#xD;
&#xD;
          -  Mentally stable and able to comply with the procedures of the study protocol&#xD;
&#xD;
          -  Patient has been listed for kidney transplantation from a deceased donor at the&#xD;
             clinical sites included in this study.&#xD;
&#xD;
          -  Negative crossmatch test prior to transplantation and no existence of donor-specific&#xD;
             antibodies&#xD;
&#xD;
          -  Receiving first or second renal transplantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Organs:&#xD;
&#xD;
          -  Organs from donors deceased due to cardiac death.&#xD;
&#xD;
          -  Organs which have not been adequately perfused during HMP, as judged by the&#xD;
             transplantation surgeon on call.&#xD;
&#xD;
        Patients:&#xD;
&#xD;
          -  Use of an investigational drug or other investigational treatment, that could&#xD;
             interfere with the outcome of the present trial, in the 30 days' period before Study&#xD;
             Day 1&#xD;
&#xD;
          -  Increased risk of thrombosis (ex. homozygous APC-resistance) or bleeding (INR&gt;1.5)&#xD;
&#xD;
          -  Anticoagulant treatment with Warfarin for indication unrelated to the kidney&#xD;
             transplantation&#xD;
&#xD;
          -  History of heparin-induced thrombocytopenia (HIT)&#xD;
&#xD;
          -  History of or positive for HIV, HBV, or HCV&#xD;
&#xD;
          -  History of oncological malignancy within the last five years, except excised squamous&#xD;
             or basal cell carcinoma of the skin&#xD;
&#xD;
          -  Scheduled to undergo multi-organ transplantation or dual kidney transplantation&#xD;
&#xD;
          -  Current drug and/or alcohol abuse&#xD;
&#xD;
          -  Known fish allergy&#xD;
&#xD;
          -  History or presence of a medical condition or disease or psychiatric condition that in&#xD;
             the investigator's assessment would place the patient at an unacceptable risk for&#xD;
             study participation&#xD;
&#xD;
          -  Lactating or pregnant women or women who intend to become pregnant&#xD;
&#xD;
          -  Women of child-bearing potential, defined as all women physiologically capable of&#xD;
             becoming pregnant, unless they are using effective methods of contraception during&#xD;
             study treatment. Acceptable birth control methods are those with a failure rate of&#xD;
             less than 1% per year when used consistently and correctly. Such methods include (in&#xD;
             &quot;Recommendations related to contraception and pregnancy testing in clinical trials&quot;,&#xD;
             supplied from www.hma.eu/):&#xD;
&#xD;
               1. Combined (estrogen and progestogen containing hormonal contraception associated&#xD;
                  with inhibition of ovulation&#xD;
&#xD;
                    -  oral&#xD;
&#xD;
                    -  intravaginal&#xD;
&#xD;
                    -  transdermal&#xD;
&#xD;
               2. progestogen-only hormonal contraception associated with inhibition of ovulation&#xD;
&#xD;
                    -  oral&#xD;
&#xD;
                    -  injectable&#xD;
&#xD;
                    -  implantable&#xD;
&#xD;
               3. intrauterine device&#xD;
&#xD;
               4. intrauterine hormone-releasing system&#xD;
&#xD;
               5. bilateral tubal occlusion&#xD;
&#xD;
               6. vasectomized partner&#xD;
&#xD;
          -  Patients who the investigator considers not eligible to give informed consent&#xD;
&#xD;
          -  Presence of ECG-based evidence of acute myocardial infarction, unstable angina,&#xD;
             decompensated heart failure, third degree of heart block or cardiac arrhythmia&#xD;
             associated with hemodynamic stability&#xD;
&#xD;
          -  Patients with any condition or any circumstance that in the opinion of the&#xD;
             investigator would make it unsafe to undergo a kidney transplantation&#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_official>
    <last_name>Amir Sedigh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Section of Transplantation Surgery, Uppsala University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Transplantationscentrum, Sahlgrenska University Hospital</name>
      <address>
        <city>Gothenburg</city>
        <zip>41345</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Transplantation Surgery, Karolinska University Hospital, Huddinge</name>
      <address>
        <city>Stockholm</city>
        <zip>14186</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Surgical Sciences, Section of Transplantation Surgery, Uppsala University Hospital</name>
      <address>
        <city>Uppsala</city>
        <zip>75185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delayed Graft Function</mesh_term>
  </condition_browse>
  <!-- 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/NCT03773211
org study id: RENAPAIR 01
nct id: NCT03773211
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluates the safety and tolerability of Renaparin in adult patients receiving a
      deceased donor kidney treated ex-vivo with Renaparin prior to transplantation. Half the
      patient group will receive a kidney treated with Renaparin, while the other half of the
      patient group will receive a kidney treated with placebo.
Kidney transplantation is the last resort for end-stage renal disease (ESRD). A key problem
      after transplantation is Delayed Graft Function (DGF). Short term, DGF will result in
      patients being put on dialysis in the immediate time-period after transplantation. In the
      longer perspective DGF is associated with increased risk of graft failure, thus decreasing
      the efficacy of the kidney transplantation.

      Renaparin is a new product under development for the prevention of DGF in association with
      kidney transplantation. The product binds to the kidney vascular endothelium and its
      pharmacological effect is based on a local and effective presentation of heparin. Renaparin
      is administered ex vivo to the kidney by adding it to the preservation solution during
      Hypothermic Machine Perfusion (HMP) prior to transplantation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Adverse Events
time frame: 30 days
description: Number and severity grade of Serious Adverse Events and Adverse Events including description of their associated MedDRA terms during the first 30 days after transplantation.
arm group label: Renaparin
arm group type: Experimental
description: Solution administered once to kidney ex-vivo
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo administered once to kidney ex-vivo
intervention type: Drug
intervention name: Renaparin
description: 50 mL added at one occasion ex-vivo to machine perfusion solution to treat kidney at least 3 hours prior to transplantation
arm group label: Renaparin
intervention type: Drug
intervention name: Placebo
description: 50 mL added at one occasion ex-vivo to machine perfusion solution to treat kidney at least 3 hours prior to transplantation
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Amir Sedigh, MD
role: Principal Investigator
affiliation: Section of Transplantation Surgery, Uppsala University Hospital
facility: 
facility: 
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Delayed Graft Function