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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 April 2015 |
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Main ID: |
NCT00885547 |
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Date of registration:
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20/04/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Prospective Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis
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Scientific title:
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Prospective Clinical Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis. |
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Date of first enrolment:
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March 2009 |
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Target sample size:
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90 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00885547 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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China
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Contacts
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Name:
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Zheng Tang, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nanjing University School of Medicine |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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IgA Nephropathy
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Intervention(s)
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Drug: tripterygium wilfordii (TW)
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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The percentage of total effect of the 3 groups and adverse event within the follow-up periods.
[Time Frame: 12 months]
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Secondary ID(s)
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NJCT-0904
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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