Prospective Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis
This study has been withdrawn prior to enrollment.
(There were so many patients drop-out.)
Sponsor:
Nanjing University School of Medicine
Information provided by:
Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT00885547
First received: April 20, 2009
Last updated: August 8, 2011
Last verified: April 2009
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Purpose
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 | Intervention |
|---|---|
|
IgA Nephropathy |
Drug: tripterygium wilfordii (TW) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prospective Clinical Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis. |
Resource links provided by NLM:
Further study details as provided by Nanjing University School of Medicine:
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 ]
| Estimated Enrollment: | 90 |
| Study Start Date: | March 2009 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: immunosuppressor |
Drug: tripterygium wilfordii (TW)
90 mg/d for 6 months
Other Name: tripterygium wilfordii
|
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).
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885547
Sponsors and Collaborators
Nanjing University School of Medicine
Investigators
| Principal Investigator: | Zheng Tang, Doctor | Nanjing University School of Medicine |
More Information
No publications provided
| Responsible Party: | Zheng Tang, Nanjing University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00885547 History of Changes |
| Other Study ID Numbers: | NJCT-0904 |
| Study First Received: | April 20, 2009 |
| Last Updated: | August 8, 2011 |
| Health Authority: | China: Food and Drug Administration |
ClinicalTrials.gov processed this record on March 03, 2015