<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/NCT02187900</url>
  </required_header>
  <id_info>
    <org_study_id>HNXY201401</org_study_id>
    <nct_id>NCT02187900</nct_id>
  </id_info>
  <brief_title>Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f.</brief_title>
  <official_title>Phase 3 Study of Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Xiangya Hospital of Central South University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether Multi-glycoside of Tripterygium Wilfordii&#xD;
      HOOK. f. is effective and safe in the treatment of IgA nephropathy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary IgA nephropathy (IgAN) is the most common form of idiopathic glomerulonephritis&#xD;
      throughout of the world. The disease is characterized by the predominant deposition of&#xD;
      polymer Gal-deﬁcient IgA1 immune complex（pGd-IgA1-IC）in the glomeruli which leads to the&#xD;
      proliferation of mesangial cells. Mycophenolate mofetil is reported to be useful in the&#xD;
      treatment of IgAN in Chinese patients, but the price is expensive together with some adverse&#xD;
      events. Tripterygium Wilfordii HOOK. f. is a traditional chinese medicine and is useful in&#xD;
      the treatment of CKD, the purpose of this study is to determine whether Multi-glycoside of&#xD;
      Tripterygium Wilfordii HOOK. f. is effective and safe in the treatment of IgA nephropathy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Anticipated">August 2015</primary_completion_date>
  <phase>Phase 3</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>Number of patients reaching remission</measure>
    <time_frame>one year</time_frame>
    <description>(i) complete remission was deﬁned as the absence of proteinuria (24-h urine protein &lt; 0.4 g/24 h), serum albumin &gt;35 g/L and Scr &lt; 1.24 mg/ dL; (ii) partial remission was deﬁned as a 24-h urine protein ≤ 3.5 g/24 h and a decline of &gt;50% of the baseline value with an Scr elevation of &lt;15% of the baseline value; (iii) no response was deﬁned as a 24-h urine protein &gt;3.5 g/24h, or a decline &lt; 50% of base- line value or increase and/or an Scr level &gt;50% of the baseline value</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Renal survival</measure>
    <time_frame>one year</time_frame>
    <description>Renal survival was estimated on the basis of a 50% increase in baseline serum creatinine concentration.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>adverse event</measure>
    <time_frame>one year</time_frame>
    <description>liver function test result abnormalities;menstrual disturbance</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>IgA Nephropathy</condition>
  <arm_group>
    <arm_group_label>TWH for the treatment of IgAN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Interventions :The dosage of 40 mg of Multi-glycoside of Tripterygium Wilfordii HOOK. f. was divided into 2 equal doses at 12-hour intervals for 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MMF for IgAN</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>MMF for the treatment of IgAN for 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH)</intervention_name>
    <description>The dosage of 40 mg of Multi-glycoside of Tripterygium Wilfordii HOOK. f. was divided into 2 equal doses at 12-hour intervals for 6 months.</description>
    <arm_group_label>TWH for the treatment of IgAN</arm_group_label>
    <other_name>Multi-glycoside of Tripterygium Wilfordii HOOK. f.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mycophenolate mofetil (MMF)</intervention_name>
    <description>Mycophenolate mofetil 1.5mg/day for the treatment of IgAN for 6 months</description>
    <arm_group_label>MMF for IgAN</arm_group_label>
    <other_name>Mycophenolate mofetil</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  urinary protein levels ≥1.0 g/24 h&#xD;
&#xD;
          -  estimated glomerular filtration rate (eGFR) ≥30 ml·min-1·1.73 m-2body surface area by&#xD;
             the MDRD formula (eGFR=194×age-0.287×serum creatinine&#xD;
&#xD;
          -  1.094(×0.739, if female) (where sCr is the serum creatinine, dry chemistry method,&#xD;
             mg/dl))&#xD;
&#xD;
          -  peripheral blood white blood cell count ≥3000×109/L&#xD;
&#xD;
          -  no other cause for tubulointerstitial lesions&#xD;
&#xD;
          -  no history of immunomodulatory agent intake before renal biopsy&#xD;
&#xD;
          -  no systemic infection&#xD;
&#xD;
          -  age between 16 and 65 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe infections&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shenghua Zhou, MD</last_name>
    <role>Study Director</role>
    <affiliation>the second xiangya hospital of CSU</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Youming Peng, M.D</last_name>
    <phone>8615802604114</phone>
  </overall_contact>
  <location>
    <facility>
      <name>The second Xiangya Hospital of CSU</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410011</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liyu He, M.D</last_name>
      <phone>8615802604114</phone>
      <email>heliyu1124@126.com</email>
    </contact>
    <investigator>
      <last_name>Liyu He, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>July 10, 2014</last_update_submitted>
  <last_update_submitted_qc>July 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Second Xiangya Hospital of Central South University</investigator_affiliation>
    <investigator_full_name>Youming Peng</investigator_full_name>
    <investigator_title>Director of the Nephrology Institute</investigator_title>
  </responsible_party>
  <keyword>Tripterygium Wilfordii HOOK. f.</keyword>
  <keyword>Mycophenolate mofetil</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>Cardiac Glycosides</mesh_term>
  </intervention_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/NCT02187900
org study id: HNXY201401
nct id: NCT02187900
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether Multi-glycoside of Tripterygium Wilfordii
      HOOK. f. is effective and safe in the treatment of IgA nephropathy.
Primary IgA nephropathy (IgAN) is the most common form of idiopathic glomerulonephritis
      throughout of the world. The disease is characterized by the predominant deposition of
      polymer Gal-deﬁcient IgA1 immune complex（pGd-IgA1-IC）in the glomeruli which leads to the
      proliferation of mesangial cells. Mycophenolate mofetil is reported to be useful in the
      treatment of IgAN in Chinese patients, but the price is expensive together with some adverse
      events. Tripterygium Wilfordii HOOK. f. is a traditional chinese medicine and is useful in
      the treatment of CKD, the purpose of this study is to determine whether Multi-glycoside of
      Tripterygium Wilfordii HOOK. f. is effective and safe in the treatment of IgA nephropathy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients reaching remission
time frame: one year
description: (i) complete remission was deﬁned as the absence of proteinuria (24-h urine protein < 0.4 g/24 h), serum albumin >35 g/L and Scr < 1.24 mg/ dL; (ii) partial remission was deﬁned as a 24-h urine protein ≤ 3.5 g/24 h and a decline of >50% of the baseline value with an Scr elevation of <15% of the baseline value; (iii) no response was deﬁned as a 24-h urine protein >3.5 g/24h, or a decline < 50% of base- line value or increase and/or an Scr level >50% of the baseline value
measure: Renal survival
time frame: one year
description: Renal survival was estimated on the basis of a 50% increase in baseline serum creatinine concentration.
measure: adverse event
time frame: one year
description: liver function test result abnormalities;menstrual disturbance
arm group label: TWH for the treatment of IgAN
arm group type: Experimental
description: Interventions :The dosage of 40 mg of Multi-glycoside of Tripterygium Wilfordii HOOK. f. was divided into 2 equal doses at 12-hour intervals for 6 months.
arm group label: MMF for IgAN
arm group type: Active Comparator
description: MMF for the treatment of IgAN for 6 months
intervention type: Drug
intervention name: Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH)
description: The dosage of 40 mg of Multi-glycoside of Tripterygium Wilfordii HOOK. f. was divided into 2 equal doses at 12-hour intervals for 6 months.
arm group label: TWH for the treatment of IgAN
other name: Multi-glycoside of Tripterygium Wilfordii HOOK. f.
intervention type: Drug
intervention name: Mycophenolate mofetil (MMF)
description: Mycophenolate mofetil 1.5mg/day for the treatment of IgAN for 6 months
arm group label: MMF for IgAN
other name: Mycophenolate mofetil
criteria: 
gender: All
minimum age: 16 Years
maximum age: 65 Years
healthy volunteers: No
last name: Shenghua Zhou, MD
role: Study Director
affiliation: the second xiangya hospital of CSU
last name: Youming Peng, M.D
phone: 8615802604114
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Second Xiangya Hospital of Central South University
investigator full name: Youming Peng
investigator title: Director of the Nephrology Institute
mesh term: Glomerulonephritis, IGA
mesh term: Mycophenolic Acid
mesh term: Cardiac Glycosides