<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/NCT02251067</url>
  </required_header>
  <id_info>
    <org_study_id>VPI-CLIN-201-AD</org_study_id>
    <nct_id>NCT02251067</nct_id>
  </id_info>
  <brief_title>Phase 2 Study to Evaluate Safety &amp; Efficacy of VPI-2690B in Diabetic Nephropathy Patients</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group, Phase 2, Two-Part Adaptive Study to Evaluate the Safety and Efficacy of VPI-2690B Injection in Patients With Nephropathy Due to Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vascular Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vascular Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether VPI-2690B Injection is effective in the&#xD;
      treatment of diabetic nephropathy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in albuminuria</measure>
    <time_frame>50 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in eGFR</measure>
    <time_frame>50 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">165</enrollment>
  <condition>Diabetic Nephropathy</condition>
  <arm_group>
    <arm_group_label>VPI-2690B low dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>6 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VPI-2690B medium dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>18 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>6 or 18 mg Placebo, administered subcutaneously every 2 weeks for 48 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VPI-2690B high dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>48 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VPI-2690B low dose</intervention_name>
    <description>Comparison of different doses of study drug</description>
    <arm_group_label>VPI-2690B low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VPI-2690B medium dose</intervention_name>
    <description>Comparison of different doses of study drug</description>
    <arm_group_label>VPI-2690B medium dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to match VPI-2690B</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VPI-2690B high dose</intervention_name>
    <description>Comparison of different doses of study drug</description>
    <arm_group_label>VPI-2690B high dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  documented diabetic nephropathy in patients with either Type 1 or Type 2 diabetics&#xD;
&#xD;
          -  HbA1c of 7.5-10.5%&#xD;
&#xD;
          -  eGFR 30-110 mL/min/1.73m2&#xD;
&#xD;
          -  stable ACEi/ARB dose regimen&#xD;
&#xD;
          -  stable blood pressure&#xD;
&#xD;
          -  BMI less than or equal to 45 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non-diabetic renal disease&#xD;
&#xD;
          -  history of solid organ or islet cell transplant&#xD;
&#xD;
          -  history of malignancy within previous 5 years&#xD;
&#xD;
          -  systemic immunosuppression therapy&#xD;
&#xD;
          -  clinically significant liver disease, hepatitis B or C or HIV&#xD;
&#xD;
          -  monoclonal antibody treatment within previous year&#xD;
&#xD;
          -  recent acute renal injury or major surgery&#xD;
&#xD;
          -  significant, recent body weight change&#xD;
&#xD;
          -  biopsy proven glomerular disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vascular Pharmaceuticals Inc Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Vascular Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tustin</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cooper City</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Coral Springs</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St. Petersburg</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Winter Park</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mt. Prospect</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Merrillville</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Morehead City</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wooster</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ponce</city>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Juan</city>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>March 27, 2017</last_update_submitted>
  <last_update_submitted_qc>March 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2017</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>Diabetic Nephropathies</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/NCT02251067
org study id: VPI-CLIN-201-AD
nct id: NCT02251067
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether VPI-2690B Injection is effective in the
      treatment of diabetic nephropathy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change from baseline in albuminuria
time frame: 50 weeks
measure: Change from baseline in eGFR
time frame: 50 weeks
arm group label: VPI-2690B low dose
arm group type: Active Comparator
description: 6 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
arm group label: VPI-2690B medium dose
arm group type: Active Comparator
description: 18 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: 6 or 18 mg Placebo, administered subcutaneously every 2 weeks for 48 weeks
arm group label: VPI-2690B high dose
arm group type: Active Comparator
description: 48 mg, VPI-2690B Injection, administered subcutaneously every 2 weeks for 48 weeks
intervention type: Drug
intervention name: VPI-2690B low dose
description: Comparison of different doses of study drug
arm group label: VPI-2690B low dose
intervention type: Drug
intervention name: VPI-2690B medium dose
description: Comparison of different doses of study drug
arm group label: VPI-2690B medium dose
intervention type: Drug
intervention name: Placebo to match VPI-2690B
arm group label: Placebo
intervention type: Drug
intervention name: VPI-2690B high dose
description: Comparison of different doses of study drug
arm group label: VPI-2690B high dose
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: No
last name: Vascular Pharmaceuticals Inc Clinical Trial
role: Study Director
affiliation: Vascular Pharmaceuticals, Inc.
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country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Diabetic Nephropathies