Prospective Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis
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ClinicalTrials.gov Identifier: NCT00885547 |
Recruitment Status :
Terminated
(low-rate of enrollment)
First Posted : April 22, 2009
Last Update Posted : April 2, 2015
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
IgA Nephropathy | Drug: tripterygium wilfordii (TW) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 90 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Prospective Clinical Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis. |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | April 2011 |
Actual Study Completion Date : | May 2011 |
Arm | Intervention/treatment |
---|---|
Experimental: immunosuppressor |
Drug: tripterygium wilfordii (TW)
90 mg/d for 6 months
Other Name: tripterygium wilfordii |
- 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 ]
- 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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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00885547
Principal Investigator: | Zheng Tang, Doctor | Nanjing University School of Medicine |
Responsible Party: | Zhi-Hong Liu, M.D., professor, Nanjing University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00885547 |
Other Study ID Numbers: |
NJCT-0904 |
First Posted: | April 22, 2009 Key Record Dates |
Last Update Posted: | April 2, 2015 |
Last Verified: | March 2015 |
Glomerulonephritis, IGA Kidney Diseases Urologic Diseases Glomerulonephritis |
Nephritis Autoimmune Diseases Immune System Diseases |