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Prospective Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis

Primary Purpose

IgA Nephropathy

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tripterygium wilfordii (TW)
Sponsored by
Nanjing University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgA Nephropathy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18-60 years old but no requirement for gender
  2. All well fit the Diagnostic Criteria for Primary IgAN and IgAN with asymptomatic abnormal urinalysis
  3. Informed consent is obtained from each research subject who agrees to conduct a periodic follow-up according to the research arrangement

Exclusion Criteria:

  1. Secondary IgA nephropathy, such as Henoch-Schönlein purpura nephritis, Lupus nephritis and so on
  2. Some secondary kidney diseases like diabetic nephropathy or other systemic diseases which may effect the pathologic and physiological function of kidney like hypertension and arteriosclerosis
  3. Severe infection
  4. Abnormality of liver function with glutamic pyruvic transaminase (GPT) or glutamic-oxal(o)acetic transaminase (GOT) more than twice upper limit of normal
  5. Women during pregnancy and lactation
  6. Patients need to procreation lately
  7. Patients treated with TW or ARB within 4 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    immunosuppressor

    Arm Description

    Outcomes

    Primary Outcome Measures

    The percentage got to complete remission (CR) of TW group, the combined treatment group, and the control group after the 3, 6 months treatment.

    Secondary Outcome Measures

    The percentage of total effect of the 3 groups and adverse event within the follow-up periods.

    Full Information

    First Posted
    April 20, 2009
    Last Updated
    March 31, 2015
    Sponsor
    Nanjing University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00885547
    Brief Title
    Prospective Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis
    Official Title
    Prospective Clinical Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Terminated
    Why Stopped
    low-rate of enrollment
    Study Start Date
    March 2009 (undefined)
    Primary Completion Date
    April 2011 (Actual)
    Study Completion Date
    May 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nanjing University School of Medicine

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to: To evaluate the latest effects of TW for IgA nephropathy (IgAN) with asymptomatic abnormal urinalysis. To evaluate the safety and tolerability of TW.
    Detailed Description
    Patients who fit the inclusion criteria will be randomly divided into three groups: TW group (TW at dosage of 90 mg/d), ARB group (the control group, valsartan at dosage of 160 mg/d) and combined treatment group (TW at dosage of 60 mg/d and valsartan at dosage of 80 mg/d).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    IgA Nephropathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    immunosuppressor
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    tripterygium wilfordii (TW)
    Other Intervention Name(s)
    tripterygium wilfordii
    Intervention Description
    90 mg/d for 6 months
    Primary Outcome Measure Information:
    Title
    The percentage got to complete remission (CR) of TW group, the combined treatment group, and the control group after the 3, 6 months treatment.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    The percentage of total effect of the 3 groups and adverse event within the follow-up periods.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18-60 years old but no requirement for gender All well fit the Diagnostic Criteria for Primary IgAN and IgAN with asymptomatic abnormal urinalysis Informed consent is obtained from each research subject who agrees to conduct a periodic follow-up according to the research arrangement Exclusion Criteria: Secondary IgA nephropathy, such as Henoch-Schönlein purpura nephritis, Lupus nephritis and so on Some secondary kidney diseases like diabetic nephropathy or other systemic diseases which may effect the pathologic and physiological function of kidney like hypertension and arteriosclerosis Severe infection Abnormality of liver function with glutamic pyruvic transaminase (GPT) or glutamic-oxal(o)acetic transaminase (GOT) more than twice upper limit of normal Women during pregnancy and lactation Patients need to procreation lately Patients treated with TW or ARB within 4 months
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zheng Tang, Doctor
    Organizational Affiliation
    Nanjing University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Prospective Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis

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