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

• ClinicalTrials.gov Identifier: NCT00885547
• Recruitment Status: Terminated
• First Posted: April 22, 2009
• Last Update Posted: April 2, 2015
• Sponsor: Nanjing University School of Medicine
• Information provided by (Responsible Party): Zhi-Hong Liu, M.D., Nanjing University School of Medicine

Tracking Information

• First Submitted Date: April 20, 2009
• First Posted Date: April 22, 2009
• Last Update Posted Date: April 2, 2015
• Study Start Date: March 2009
• Actual Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 20, 2009): 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 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: April 20, 2009): The percentage of total effect of the 3 groups and adverse event within the follow-up periods. [ Time Frame: 12 months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.

Brief Summary

The purpose of this study is to:

1. To evaluate the latest effects of TW for IgA nephropathy (IgAN) with asymptomatic abnormal urinalysis.
2. 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).
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: IgA Nephropathy

Intervention

Drug: tripterygium wilfordii (TW)

90 mg/d for 6 months

Other Name: tripterygium wilfordii

Study Arms

Experimental: immunosuppressor

Intervention: Drug: tripterygium wilfordii (TW)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 20, 2009): 90
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 2011
• Actual Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: China

Administrative Information

• NCT Number: NCT00885547
• Other Study ID Numbers: NJCT-0904
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Zhi-Hong Liu, M.D., Nanjing University School of Medicine
• Study Sponsor: Nanjing University School of Medicine
• Collaborators: Not Provided

Investigators

• Principal Investigator: Zheng Tang, Doctor; Nanjing University School of Medicine

• PRS Account: Nanjing University School of Medicine
• Verification Date: March 2015