<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/NCT02205372</url>
  </required_header>
  <id_info>
    <org_study_id>MT-3995-J04</org_study_id>
    <nct_id>NCT02205372</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Pharmacokinetic Study of MT-3995 at a Low Dose in Subjects With Diabetic Nephropathy</brief_title>
  <official_title>A Phase II, Randomised, Double-blind, Placebo-controlled Study of MT-3995 (Low Dose) in Subjects With Diabetic Nephropathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mitsubishi Tanabe Pharma Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mitsubishi Tanabe Pharma Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995&#xD;
      in Subjects with Diabetic Nephropathy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <phase>Phase 1/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>Frequency and nature of treatment-emergent adverse events and serious adverse events.</measure>
    <time_frame>20 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma concentrations of MT-3995</measure>
    <time_frame>20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma concentrations of major metabolite of MT-3995</measure>
    <time_frame>20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Urine albumin-to-creatinine ratio (UACR)</measure>
    <time_frame>20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in blood pressure</measure>
    <time_frame>20 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Diabetic Nephropathy</condition>
  <arm_group>
    <arm_group_label>MT-3995</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MT-3995</intervention_name>
    <arm_group_label>MT-3995</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with Type 2 diabetes mellitus and diabetic nephropathy, who have been treated&#xD;
             with a stable dose of angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin&#xD;
             II receptor blocker (ARB)&#xD;
&#xD;
          -  Glycosylated haemoglobin (HbA1c) ≤10.5%&#xD;
&#xD;
          -  Subject with albuminuria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic&#xD;
             disorder, secondary diabetes mellitus (Cushing's syndrome, steroidogenic diabetes).&#xD;
&#xD;
          -  Serum potassium level &lt;3.5 or &gt;5.0 mmol/L&#xD;
&#xD;
          -  Subjects who had acute kidney injury within 3 months prior to baseline or have&#xD;
             undergone hemodialysis at any time prior to randomisation&#xD;
&#xD;
          -  Subjects with clinically significant hypotension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Masaomi Nangaku, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Division of Nephrology and Endocrinology University of Tokyo School of medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kazuoki Kondou, Adviｓer</last_name>
    <role>Study Director</role>
    <affiliation>Mitsubishi Tanabe Pharma Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Touei Hospital</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>July 27, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>September 14, 2015</last_update_submitted>
  <last_update_submitted_qc>September 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetic Nephropathy</keyword>
  <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/NCT02205372
org study id: MT-3995-J04
nct id: NCT02205372
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995
      in Subjects with Diabetic Nephropathy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Frequency and nature of treatment-emergent adverse events and serious adverse events.
time frame: 20 weeks
measure: Plasma concentrations of MT-3995
time frame: 20 weeks
measure: Plasma concentrations of major metabolite of MT-3995
time frame: 20 weeks
measure: Change from baseline in Urine albumin-to-creatinine ratio (UACR)
time frame: 20 weeks
measure: Change from baseline in blood pressure
time frame: 20 weeks
arm group label: MT-3995
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: MT-3995
arm group label: MT-3995
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Masaomi Nangaku, Professor
role: Study Director
affiliation: Division of Nephrology and Endocrinology University of Tokyo School of medicine
last name: Kazuoki Kondou, Adviｓer
role: Study Director
affiliation: Mitsubishi Tanabe Pharma Corporation
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Diabetic Nephropathies