<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/NCT03270956</url>
  </required_header>
  <id_info>
    <org_study_id>REGEN-003</org_study_id>
    <nct_id>NCT03270956</nct_id>
  </id_info>
  <brief_title>A Study of Autologous Renal Autologous Cell Therapy (REACT) in Patients With Diabetic Chronic Kidney Disease</brief_title>
  <official_title>A Phase II, Open-Label Safety and Tolerability Study of an Renal Autologous Cell Therapy (REACT) in Patients With Type 2 Diabetes and Chronic Kidney Disease (REGEN-003)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prokidney</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CTI Clinical Trial and Consulting Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Prokidney</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the present study is to assess the safety and efficacy of up to 2 injections&#xD;
      of REACT given 6 months (+4 weeks) apart (maximum).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All subjects enrolled will receive REACT. Subjects will receive their first REACT injection&#xD;
      as soon as the REACT product is manufactured and shipped to the clinical site. After 6 months&#xD;
      (+4 weeks), a second injection will be given, as appropriate. Each subject's baseline rate of&#xD;
      renal decline, based on adequate historical clinical data obtained 24 months prior to&#xD;
      screening visit, will serve as a comparator for monitoring the rate of progression of renal&#xD;
      insufficiency over time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 25, 2018</start_date>
  <completion_date type="Actual">November 17, 2022</completion_date>
  <primary_completion_date type="Actual">November 17, 2022</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Open label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Procedure and/or product related adverse events</measure>
    <time_frame>Through 24 months following last REACT injection</time_frame>
    <description>Incidence (percentage of subjects) with procedure and/or product related adverse events by System Order Class and Preferred Term</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Renal specific adverse events</measure>
    <time_frame>Through 24 months following last REACT injection</time_frame>
    <description>Incidence (percentage of subjects) with renal-specific adverse events by System Order Class and Preferred Term</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <condition>Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>Renal Autologous Cell Therapy (REACT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Renal Autologous Cell Therapy (REACT) Treatment - Patients will receive their first treatment of 2 injections of REACT as soon as REACT product is made available.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Renal Autologous Cell Therapy (REACT)</intervention_name>
    <description>Autologous selected renal cells (SRC)</description>
    <arm_group_label>Renal Autologous Cell Therapy (REACT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subject is male or female, 30 to 65 years of age on the date of informed consent.&#xD;
&#xD;
          2. The subject has an established diagnosis of T2DM.&#xD;
&#xD;
          3. The subject has an established diagnosis of diabetic nephropathy as the underlying&#xD;
             cause of renal disease.&#xD;
&#xD;
          4. The subject has an established diagnosis of CKD not requiring renal dialysis, defined&#xD;
             as having an eGFR between 14 and 20 mL/min/1.73m² inclusive at the Screening Visit and&#xD;
             prior to REACT injection.&#xD;
&#xD;
          5. The subject has blood pressure less than 150/90 at the Screening Visit, prior to renal&#xD;
             biopsy, and prior to REACT injection(s). Note BP should not be significantly below the&#xD;
             previously recorded stable pressure.&#xD;
&#xD;
          6. A minimum of 3 measurements of eGFR or sCr should be obtained at least 3 months apart&#xD;
             prior to the Screening Visit or within the previous 24 months to define the rate of&#xD;
             progression of CKD. The subject should have adequate, historical clinical data to&#xD;
             provide a reasonable estimate of the rate of progression of CKD. The Medical Monitor&#xD;
             may be consulted to ensure there is sufficient data.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The subject has a history of type 1 diabetes mellitus.&#xD;
&#xD;
          2. The subject has a history of renal transplantation.&#xD;
&#xD;
          3. The subject has a serum HbA1c level greater than 10% at the Screening Visit.&#xD;
&#xD;
          4. The subject has uncontrolled diabetes (defined as metabolically unstable by the&#xD;
             Investigator).&#xD;
&#xD;
          5. The subject has hemoglobin levels less than 9 g/dL prior to each REACT injection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ashley Johns</last_name>
    <role>Study Director</role>
    <affiliation>Prokidney</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arizona [WITHDRAWN]</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boise Kidney &amp; Hypertension Institute</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina- Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University [WITHDRAWN]</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>January 6, 2023</last_update_submitted>
  <last_update_submitted_qc>January 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2023</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>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_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/NCT03270956
org study id: REGEN-003
nct id: NCT03270956
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
The purpose of the present study is to assess the safety and efficacy of up to 2 injections
      of REACT given 6 months (+4 weeks) apart (maximum).
All subjects enrolled will receive REACT. Subjects will receive their first REACT injection
      as soon as the REACT product is manufactured and shipped to the clinical site. After 6 months
      (+4 weeks), a second injection will be given, as appropriate. Each subject's baseline rate of
      renal decline, based on adequate historical clinical data obtained 24 months prior to
      screening visit, will serve as a comparator for monitoring the rate of progression of renal
      insufficiency over time.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Open label
measure: Procedure and/or product related adverse events
time frame: Through 24 months following last REACT injection
description: Incidence (percentage of subjects) with procedure and/or product related adverse events by System Order Class and Preferred Term
measure: Renal specific adverse events
time frame: Through 24 months following last REACT injection
description: Incidence (percentage of subjects) with renal-specific adverse events by System Order Class and Preferred Term
arm group label: Renal Autologous Cell Therapy (REACT)
arm group type: Experimental
description: Renal Autologous Cell Therapy (REACT) Treatment - Patients will receive their first treatment of 2 injections of REACT as soon as REACT product is made available.
intervention type: Biological
intervention name: Renal Autologous Cell Therapy (REACT)
description: Autologous selected renal cells (SRC)
arm group label: Renal Autologous Cell Therapy (REACT)
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ashley Johns
role: Study Director
affiliation: Prokidney
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No