<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/NCT03841448</url>
  </required_header>
  <id_info>
    <org_study_id>ALN-CC5-005</org_study_id>
    <secondary_id>2018-002716-27</secondary_id>
    <nct_id>NCT03841448</nct_id>
  </id_info>
  <brief_title>A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN)</brief_title>
  <official_title>A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients With IgA Nephropathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alnylam Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alnylam Pharmaceuticals</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 this study is to evaluate the effect of cemdisiran on proteinuria in adults&#xD;
      with immunoglobulin A nephropathy (IgAN), who excrete &gt;1 gram (gm) of protein per day despite&#xD;
      standard of care, which includes treatment with angiotensin-converting enzyme (ACE)&#xD;
      inhibitors or angiotensin receptor blockers (ARBs). These patients are at high risk for&#xD;
      progression of kidney disease, which can result in end-stage renal failure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 24, 2019</start_date>
  <completion_date type="Anticipated">February 28, 2025</completion_date>
  <primary_completion_date type="Actual">March 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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) as Measured in 24-hour Urine at Week 32</measure>
    <time_frame>Baseline, Week 32</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in 24-Hour Proteinuria at Week 32</measure>
    <time_frame>Baseline, Week 32</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Partial Clinical Remission at Week 32</measure>
    <time_frame>Week 32</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with &gt;50% Reduction in 24-hour Proteinuria at Week 32</measure>
    <time_frame>Week 32</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) as Measured in a Spot Urine at Week 32</measure>
    <time_frame>Baseline, Week 32</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hematuria at Week 32</measure>
    <time_frame>Baseline, Week 32</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Adverse Events (AEs)</measure>
    <time_frame>Up to Week 240</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>IgA Nephropathy (IgAN)</condition>
  <condition>Berger Disease</condition>
  <condition>Glomerulonephritis, IgA</condition>
  <arm_group>
    <arm_group_label>Cemdisiran</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive cemdisiran during the Treatment and optional Open-Label Extension (OLE) Periods in combination with standard of care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive matching placebo during the Treatment Period in combination with standard of care. During the optional OLE Period participants will receive cemdisiran in combination with standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Normal saline (0.9% NaCl) matching volume of cemdisiran doses will be administered SC.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cemdisiran</intervention_name>
    <description>Cemdisiran will be administered by subcutaneous (SC) injection.</description>
    <arm_group_label>Cemdisiran</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>ALN-CC5</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with primary IgAN&#xD;
&#xD;
          -  Currently being treated for IgAN with stable, optimal therapy, including an ACE&#xD;
             inhibitor or an ARB or a direct renin-inhibitor&#xD;
&#xD;
          -  Has urine protein greater than or equal to 1 gram/24-hour&#xD;
&#xD;
          -  Has hematuria (blood cells present in urine)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has renal disease other than IgAN&#xD;
&#xD;
          -  Has a diagnosis of rapidly progressive glomerulonephritis&#xD;
&#xD;
          -  Has a diagnosis of Henoch-Schonlein Purpura (IgA Vasculitis)&#xD;
&#xD;
          -  Has poor kidney function with estimated glomerular filtration rate (eGFR) &lt;30&#xD;
             mL/min/1.73 m^2&#xD;
&#xD;
          -  Has known human immunodeficiency virus (HIV) infection, hepatitis C virus (HCV)&#xD;
             infection or hepatitis B virus (HBV) infection&#xD;
&#xD;
          -  Has on-going high blood pressure&#xD;
&#xD;
          -  Treated with systemic corticosteroids for more than 7 days, or other immunosuppressant&#xD;
             agents in the past 6 months&#xD;
&#xD;
          -  Received an organ transplant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Alnylam Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Brampton</city>
        <state>Ontario</state>
        <zip>L6T0G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Annonay</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>La Tronche</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Mulhouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Kuala Lumpur</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Kuantan</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Serdang</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Manila</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Quezon City</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Córdoba</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Girona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Huddinge</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Linköping</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Site</name>
      <address>
        <city>Leicester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
    <country>Malaysia</country>
    <country>Philippines</country>
    <country>Singapore</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>February 13, 2019</study_first_submitted>
  <study_first_submitted_qc>February 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>March 18, 2023</last_update_submitted>
  <last_update_submitted_qc>March 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 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>Glomerulonephritis, IGA</mesh_term>
    <mesh_term>Glomerulonephritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>September 12, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03841448
org study id: ALN-CC5-005
secondary id: 2018-002716-27
nct id: NCT03841448
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the effect of cemdisiran on proteinuria in adults
      with immunoglobulin A nephropathy (IgAN), who excrete >1 gram (gm) of protein per day despite
      standard of care, which includes treatment with angiotensin-converting enzyme (ACE)
      inhibitors or angiotensin receptor blockers (ARBs). These patients are at high risk for
      progression of kidney disease, which can result in end-stage renal failure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Percentage Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) as Measured in 24-hour Urine at Week 32
time frame: Baseline, Week 32
measure: Percent Change from Baseline in 24-Hour Proteinuria at Week 32
time frame: Baseline, Week 32
measure: Percentage of Participants with Partial Clinical Remission at Week 32
time frame: Week 32
measure: Percentage of Participants with >50% Reduction in 24-hour Proteinuria at Week 32
time frame: Week 32
measure: Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) as Measured in a Spot Urine at Week 32
time frame: Baseline, Week 32
measure: Change From Baseline in Hematuria at Week 32
time frame: Baseline, Week 32
measure: Frequency of Adverse Events (AEs)
time frame: Up to Week 240
arm group label: Cemdisiran
arm group type: Experimental
description: Participants will receive cemdisiran during the Treatment and optional Open-Label Extension (OLE) Periods in combination with standard of care.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will receive matching placebo during the Treatment Period in combination with standard of care. During the optional OLE Period participants will receive cemdisiran in combination with standard of care.
intervention type: Drug
intervention name: Placebo
description: Normal saline (0.9% NaCl) matching volume of cemdisiran doses will be administered SC.
arm group label: Placebo
intervention type: Drug
intervention name: Cemdisiran
description: Cemdisiran will be administered by subcutaneous (SC) injection.
arm group label: Cemdisiran
arm group label: Placebo
other name: ALN-CC5
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Alnylam Pharmaceuticals
facility: 
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country: Canada
country: France
country: Malaysia
country: Philippines
country: Singapore
country: Spain
country: Sweden
country: Taiwan
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Glomerulonephritis, IGA
mesh term: Glomerulonephritis
sharing ipd: No
submitted: September 12, 2023