<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/NCT04419467</url>
  </required_header>
  <id_info>
    <org_study_id>CSL346_2001</org_study_id>
    <nct_id>NCT04419467</nct_id>
  </id_info>
  <brief_title>Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease</brief_title>
  <official_title>A Phase 2a, Double-blind, Randomized, Placebo-controlled, Proof of Concept Study of Vascular Endothelial Growth Factor (VEGF)-B Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CSL Behring</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CSL Behring</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase 2a, double-blind, randomized, placebo-controlled study will assess the efficacy,&#xD;
      safety, tolerability, and pharmacokinetics (PK), of repeat doses of CSL346 in subjects with&#xD;
      diabetic kidney disease (DKD) and albuminuria receiving standard of care treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 14, 2020</start_date>
  <completion_date type="Actual">October 24, 2022</completion_date>
  <primary_completion_date type="Actual">October 24, 2022</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change in log-transformed urinary albumin-to-creatinine ratio (ACR)</measure>
    <time_frame>Baseline up to Week 16</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with treatment-emergent adverse events (TEAEs)</measure>
    <time_frame>Up to 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects with TEAEs</measure>
    <time_frame>Up to 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events of special interest (AESIs)</measure>
    <time_frame>Up to 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects with AESIs</measure>
    <time_frame>Up to 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed value and mean change from Baseline in serum creatinine</measure>
    <time_frame>Baseline up to 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed value and mean change from Baseline in estimated glomerular filtration rate (eGFR)</measure>
    <time_frame>Baseline up to 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed value and mean change from Baseline in systolic blood pressure</measure>
    <time_frame>Baseline up to 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed value and mean change from Baseline in diastolic blood pressure</measure>
    <time_frame>Baseline up to 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum concentration (Cmax) after IV loading dose of CSL346 in serum samples</measure>
    <time_frame>Up to 120 minutes after the IV loading dose for CSL346</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reach Cmax in serum (Tmax) after IV loading dose of CSL346 in serum samples</measure>
    <time_frame>Up to 120 minutes after the IV loading dose for CSL346</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax after first SC dose of CSL346 in serum samples</measure>
    <time_frame>From Day 1 to Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax after first SC dose of CSL346 in serum samples</measure>
    <time_frame>From Day 1 to Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve in first dosing interval</measure>
    <time_frame>From Day 1 to Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trough concentration after each dose</measure>
    <time_frame>29 days after each dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects positive for anti-drug antibodies</measure>
    <time_frame>Weeks 4, 8, and 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects positive for anti-drug antibodies</measure>
    <time_frame>Weeks 4, 8, and 16</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">114</enrollment>
  <condition>Diabetic Kidney Disease (DKD)</condition>
  <arm_group>
    <arm_group_label>CSL346 (low dose)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CSL346 (high dose)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Administered as a single IV loading dose followed by SC infusions</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CSL346</intervention_name>
    <description>VEGF-B antagonist monoclonal antibody</description>
    <arm_group_label>CSL346 (high dose)</arm_group_label>
    <arm_group_label>CSL346 (low dose)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Normal saline</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects ≥ 25 years of age with a diagnosis of type 2 diabetes&#xD;
             mellitus (T2DM)&#xD;
&#xD;
          -  Urinary ACR ≥ 150 mg/g&#xD;
&#xD;
          -  eGFR ≥ 60 mL/min/1.73m2&#xD;
&#xD;
          -  Glycosylated HbA1c &lt; 12%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current diagnosis of type 1 diabetes mellitus&#xD;
&#xD;
          -  History of acute kidney injury or chronic dialysis/renal transplant&#xD;
&#xD;
          -  Uncontrolled hypertension or class III / IV heart failure&#xD;
&#xD;
          -  Left ventricular ejection fraction &lt; 50% by echocardiogram&#xD;
&#xD;
          -  Troponin-I &gt; the upper reference limit&#xD;
&#xD;
          -  b-type natriuretic peptide &gt; 200 pg/mL&#xD;
&#xD;
          -  ALT &gt; 2x the upper limit of normal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>CSL Behring</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>California Kidney Specialists (CKS) - Citrus Office</name>
      <address>
        <city>Covina</city>
        <state>California</state>
        <zip>91702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Research - Fresno</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Torrance Clinical Research (TCR) - Lomita</name>
      <address>
        <city>Lomita</city>
        <state>California</state>
        <zip>90717</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renal Medical Associate/NARI</name>
      <address>
        <city>Lynwood</city>
        <state>California</state>
        <zip>90260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amicis Research Center</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Medical Research Associates, Inc</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riverside Nephrology Group</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Orange Endocrinology</name>
      <address>
        <city>Ocoee</city>
        <state>Florida</state>
        <zip>34761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East-West Medical Research Institute</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omega Clinical Research</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renal and Transplant Associates</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Missouri Health System</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palm Medical Group, LLC - Las Vegas</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Thyroid &amp; Parathyroid Disorders</name>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <zip>10301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physicians East, P.A. - Endocrinology</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University School of Medicine</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juno Research, L.L.C.</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Endocrine Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77079</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renal Associates, P.A. - San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Primary Care Providers of Texas</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diabetes and Metabolism Specialists (DMS) - San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hunter Diabetes Centre - The AIM Centre</name>
      <address>
        <city>Merewether</city>
        <state>New South Wales</state>
        <zip>2291</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent's Hospital</name>
      <address>
        <city>Fitzroy</city>
        <state>Victoria</state>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Austin Hospital</name>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Melbourne Hospital</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3052</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunshine Hospital</name>
      <address>
        <city>St Albans</city>
        <state>Victoria</state>
        <zip>3021</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lyell McEwin Hospital</name>
      <address>
        <city>Elizabeth Vale</city>
        <zip>5112</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1240130 - University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>3760045 - Kaplan Medical Center</name>
      <address>
        <city>Reẖovot</city>
        <zip>76100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>3760044 - Tel Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv-Yafo</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Middlemore Hospital</name>
      <address>
        <city>Auckland</city>
        <zip>2025</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christchurch Hospital</name>
      <address>
        <city>Christchurch</city>
        <zip>8011</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lipid and Diabetes Research Group</name>
      <address>
        <city>Christchurch</city>
        <zip>8011</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endocrine Associates - Wellington</name>
      <address>
        <city>Wellington</city>
        <zip>6140</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundación de Investigación</name>
      <address>
        <city>San Juan</city>
        <zip>00927</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Puerto Rico - Puerto Rico Clinical and TRC</name>
      <address>
        <city>San Juan</city>
        <zip>00935</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Israel</country>
    <country>New Zealand</country>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>November 10, 2022</last_update_submitted>
  <last_update_submitted_qc>November 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2022</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.&#xD;
Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.&#xD;
If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.</ipd_time_frame>
    <ipd_access_criteria>Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.&#xD;
An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.&#xD;
The requesting party must execute an appropriate data sharing agreement before IPD will be made available.</ipd_access_criteria>
  </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/NCT04419467
org study id: CSL346_2001
nct id: NCT04419467
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This phase 2a, double-blind, randomized, placebo-controlled study will assess the efficacy,
      safety, tolerability, and pharmacokinetics (PK), of repeat doses of CSL346 in subjects with
      diabetic kidney disease (DKD) and albuminuria receiving standard of care treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Mean change in log-transformed urinary albumin-to-creatinine ratio (ACR)
time frame: Baseline up to Week 16
measure: Number of subjects with treatment-emergent adverse events (TEAEs)
time frame: Up to 24 weeks
measure: Percentage of subjects with TEAEs
time frame: Up to 24 weeks
measure: Number of subjects with adverse events of special interest (AESIs)
time frame: Up to 24 weeks
measure: Percentage of subjects with AESIs
time frame: Up to 24 weeks
measure: Observed value and mean change from Baseline in serum creatinine
time frame: Baseline up to 24 weeks
measure: Observed value and mean change from Baseline in estimated glomerular filtration rate (eGFR)
time frame: Baseline up to 24 weeks
measure: Observed value and mean change from Baseline in systolic blood pressure
time frame: Baseline up to 24 weeks
measure: Observed value and mean change from Baseline in diastolic blood pressure
time frame: Baseline up to 24 weeks
measure: Maximum concentration (Cmax) after IV loading dose of CSL346 in serum samples
time frame: Up to 120 minutes after the IV loading dose for CSL346
measure: Time to reach Cmax in serum (Tmax) after IV loading dose of CSL346 in serum samples
time frame: Up to 120 minutes after the IV loading dose for CSL346
measure: Cmax after first SC dose of CSL346 in serum samples
time frame: From Day 1 to Day 29
measure: Tmax after first SC dose of CSL346 in serum samples
time frame: From Day 1 to Day 29
measure: Area under the concentration-time curve in first dosing interval
time frame: From Day 1 to Day 29
measure: Trough concentration after each dose
time frame: 29 days after each dose
measure: Number of subjects positive for anti-drug antibodies
time frame: Weeks 4, 8, and 16
measure: Percentage of subjects positive for anti-drug antibodies
time frame: Weeks 4, 8, and 16
arm group label: CSL346 (low dose)
arm group type: Experimental
description: Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions
arm group label: CSL346 (high dose)
arm group type: Experimental
description: Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions
arm group label: Placebo
arm group type: Placebo Comparator
description: Administered as a single IV loading dose followed by SC infusions
intervention type: Biological
intervention name: CSL346
description: VEGF-B antagonist monoclonal antibody
arm group label: CSL346 (high dose)
arm group label: CSL346 (low dose)
intervention type: Drug
intervention name: Placebo
description: Normal saline
arm group label: Placebo
criteria: 
gender: All
minimum age: 25 Years
maximum age: N/A
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: CSL Behring
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country: Australia
country: Canada
country: Israel
country: New Zealand
country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Diabetic Nephropathies
sharing ipd: Yes
ipd description: CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.
If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.
ipd access criteria: Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.
An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.
The requesting party must execute an appropriate data sharing agreement before IPD will be made available.