Prospective Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis
This study has been terminated.
(low-rate of enrollment)
Information provided by (Responsible Party):
Zhi-Hong Liu, M.D., Nanjing University School of Medicine
First received: April 20, 2009
Last updated: March 31, 2015
Last verified: March 2015
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.
Drug: tripterygium wilfordii (TW)
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Prospective Clinical Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis.
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. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The percentage of total effect of the 3 groups and adverse event within the follow-up periods. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2011 (Final data collection date for primary outcome measure)
Drug: tripterygium wilfordii (TW)
90 mg/d for 6 months
Other Name: tripterygium wilfordii
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).
|Ages Eligible for Study:
||18 Years to 60 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885547
Nanjing University School of Medicine
||Zheng Tang, Doctor
||Nanjing University School of Medicine
No publications provided
||Zhi-Hong Liu, M.D., professor, Nanjing University School of Medicine
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 20, 2009
||March 31, 2015
||China: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 03, 2015
Immune System Diseases