<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/NCT02981212</url>
  </required_header>
  <id_info>
    <org_study_id>062IGA15-1D</org_study_id>
    <nct_id>NCT02981212</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of a Combination of Mycophenolate Mofetil and Corticosteroid in Advanced IgA Nephropathy</brief_title>
  <acronym>AIGA</acronym>
  <official_title>Multi-center, Randomized, Open Label, Comparative, Phase IV Study to Evaluate the Efficacy and Safety of a Combination of Mycophenolate Mofetil and Corticosteroid for 48 Weeks in Advanced IgA Nephropathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chong Kun Dang Pharmaceutical Corp.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kyung Hee University Hospital at Gangdong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kyungpook National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pusan National University Yangsan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Inje University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Seoul St. Mary's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chonbuk National University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this clinical study is to evaluate the efficacy and safety of that test group&#xD;
      was administered with Mycophenolate Mofetil in combination with corticosteroid in patients&#xD;
      with advanced IgA nephropathy. The control group will be observed for up to 48 weeks without&#xD;
      administration of Mycophenolate Mofetil.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The subject who signed the written agreement to participate in the clinical trial evaluates&#xD;
      the conformity and then 1: 1 randomly allocated.&#xD;
&#xD;
      The study group were taken 48 weeks with MYREPT ® capsules in combination with&#xD;
      corticosteroids and the control group were asked to preserve the conservative treatment&#xD;
      regimen prior to the clinical trial registration Maintenance.&#xD;
&#xD;
      The subject who started taking the study medicine will carry out the examination and&#xD;
      procedure if it has to be carried out for the visit via outpatient clinic at 4 weeks, 12&#xD;
      weeks, 24 weeks, 36 weeks, 48 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2016</start_date>
  <completion_date type="Anticipated">October 2018</completion_date>
  <primary_completion_date type="Anticipated">August 2018</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Remission rate (complete / partial)</measure>
    <time_frame>up to 48 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Remission rate (complete / partial)</measure>
    <time_frame>at 12 weeks, at 24 weeks, at 36 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>eGFR(estimated glomerular filtration rate) by MDRD(modification of diet in renal disease)</measure>
    <time_frame>at 24 weeks, at 36 weeks, at 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of renal replacement therapy</measure>
    <time_frame>up to 48 weeks</time_frame>
    <description>renal replacement therapy; dialysis, new transplant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The average time to occurrence of renal replacement therapy</measure>
    <time_frame>up to 48 weeks</time_frame>
    <description>renal replacement therapy; dialysis, new transplant</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>IgA Nephropathy</condition>
  <arm_group>
    <arm_group_label>Mycophenolate Mofetil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MYREPT® capsule(CKDpharm, KOREA) and corticosteroid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conservative treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>maintain conservative treatment (ACE inhibitor or ARB)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mycophenolate Mofetil</intervention_name>
    <description>less than 80 kg: 1,500 mg / day , 80 kg or more: 2,000 mg / day divided twice a day and administered orally</description>
    <arm_group_label>Mycophenolate Mofetil</arm_group_label>
    <other_name>MYREPT®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACE inhibitor</intervention_name>
    <description>maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization</description>
    <arm_group_label>Conservative treatment</arm_group_label>
    <other_name>conservative treatment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Corticosteroid</intervention_name>
    <description>combination with Mycophenolate Mofetil</description>
    <arm_group_label>Mycophenolate Mofetil</arm_group_label>
    <other_name>prednisolone</other_name>
    <other_name>methyprednisolone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ARB</intervention_name>
    <description>maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization</description>
    <arm_group_label>Conservative treatment</arm_group_label>
    <other_name>conservative treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Patient aged 19 to 65 years old&#xD;
&#xD;
          2. Diagnosed with IgA nephropathy&#xD;
&#xD;
          3. Confirmed with Proteinuria more than 1.0 g / day at least twice within 6 months from&#xD;
             the time of screening&#xD;
&#xD;
          4. If eGFR (by MDRD) is &lt;50 mL / min / 1.73 m^2, ≥ 15 mL / min / 1.73 m^2&#xD;
&#xD;
          5. ACE inhibitor or ARB for at least 3 months&#xD;
&#xD;
          6. Willing and able to provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. If eGFR (by MDRD) is &lt;15 mL / min / 1.73 m^2&#xD;
&#xD;
          2. Blood pressure is SBP&gt; 160 mmHg or DBP&gt; 100 mmHg&#xD;
&#xD;
          3. Systemic infection or have been diagnosed with cancer within the last 5 years&#xD;
             (excluding treatment squamous cell or basal cell carcinoma skin cancer)&#xD;
&#xD;
          4. serious digestive disorder&#xD;
&#xD;
          5. WBC &lt;3000 / mm^3&#xD;
&#xD;
          6. Acute (within 4 weeks) or chronic(need to treatments) allergic/hypersensitivity&#xD;
             reaction in the history of Investigational drugs&#xD;
&#xD;
          7. Administration of other Investigational drugs within 28days before screening period&#xD;
&#xD;
          8. Administration of Investigator drug or other immunosuppressants within 84days before&#xD;
             screening period&#xD;
&#xD;
          9. Women in pregnant or breast-feeding or don't using adequate contraception.&#xD;
&#xD;
         10. Patient has conversation impairment because alcohol or drugs addiction history within&#xD;
             6months or mental illness, etc.&#xD;
&#xD;
         11. In investigator's judgment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>BEOMSUK KIM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Severance Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>EUNJU JUNG</last_name>
    <phone>82-10-5414-7760</phone>
    <email>oakly74@nate.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>JONGHYUK LEE</last_name>
    <phone>82-10-5599-1199</phone>
    <email>leejongh@ckdpharm.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>EUNU JUNG</last_name>
      <phone>82-10-5414-7760</phone>
      <email>oakly74@nate.com</email>
    </contact>
    <investigator>
      <last_name>CHANDUK KIM, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>DONGWON LEE, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>SANGHO LEE, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>BUMSOON CHOI, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>SANGYEOB HAN, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>SIK LEE, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>November 30, 2016</last_update_submitted>
  <last_update_submitted_qc>November 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yonsei University</investigator_affiliation>
    <investigator_full_name>Beom Seok Kim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mycophenolic Acid</mesh_term>
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Angiotensin-Converting Enzyme Inhibitors</mesh_term>
  </intervention_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/NCT02981212
org study id: 062IGA15-1D
nct id: NCT02981212
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this clinical study is to evaluate the efficacy and safety of that test group
      was administered with Mycophenolate Mofetil in combination with corticosteroid in patients
      with advanced IgA nephropathy. The control group will be observed for up to 48 weeks without
      administration of Mycophenolate Mofetil.
The subject who signed the written agreement to participate in the clinical trial evaluates
      the conformity and then 1: 1 randomly allocated.

      The study group were taken 48 weeks with MYREPT ® capsules in combination with
      corticosteroids and the control group were asked to preserve the conservative treatment
      regimen prior to the clinical trial registration Maintenance.

      The subject who started taking the study medicine will carry out the examination and
      procedure if it has to be carried out for the visit via outpatient clinic at 4 weeks, 12
      weeks, 24 weeks, 36 weeks, 48 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Remission rate (complete / partial)
time frame: up to 48 weeks
measure: Remission rate (complete / partial)
time frame: at 12 weeks, at 24 weeks, at 36 weeks
measure: eGFR(estimated glomerular filtration rate) by MDRD(modification of diet in renal disease)
time frame: at 24 weeks, at 36 weeks, at 48 weeks
measure: The incidence of renal replacement therapy
time frame: up to 48 weeks
description: renal replacement therapy; dialysis, new transplant
measure: The average time to occurrence of renal replacement therapy
time frame: up to 48 weeks
description: renal replacement therapy; dialysis, new transplant
arm group label: Mycophenolate Mofetil
arm group type: Experimental
description: MYREPT® capsule(CKDpharm, KOREA) and corticosteroid
arm group label: Conservative treatment
arm group type: Active Comparator
description: maintain conservative treatment (ACE inhibitor or ARB)
intervention type: Drug
intervention name: Mycophenolate Mofetil
description: less than 80 kg: 1,500 mg / day , 80 kg or more: 2,000 mg / day divided twice a day and administered orally
arm group label: Mycophenolate Mofetil
other name: MYREPT®
intervention type: Drug
intervention name: ACE inhibitor
description: maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization
arm group label: Conservative treatment
other name: conservative treatment
intervention type: Drug
intervention name: Corticosteroid
description: combination with Mycophenolate Mofetil
arm group label: Mycophenolate Mofetil
other name: prednisolone
other name: methyprednisolone
intervention type: Drug
intervention name: ARB
description: maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization
arm group label: Conservative treatment
other name: conservative treatment
criteria: 
gender: All
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: No
last name: BEOMSUK KIM
role: Principal Investigator
affiliation: Severance Hospital
last name: EUNJU JUNG
phone: 82-10-5414-7760
email: oakly74@nate.com
last name: JONGHYUK LEE
phone: 82-10-5599-1199
email: leejongh@ckdpharm.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Yonsei University
investigator full name: Beom Seok Kim
investigator title: Professor
mesh term: Kidney Diseases
mesh term: Glomerulonephritis, IGA
mesh term: Mycophenolic Acid
mesh term: Prednisolone
mesh term: Angiotensin-Converting Enzyme Inhibitors
sharing ipd: No