NCT00885547TerminatedNot Applicable
Prospective Clinical Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis.
Nanjing University School of Medicine0 sites90 target enrollmentStarted: March 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 90
- Primary Endpoint
- The percentage got to complete remission (CR) of TW group, the combined treatment group, and the control group after the 3, 6 months treatment.
Study Overview
Brief Summary
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- 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
Arms & Interventions
immunosuppressor
Experimental
Intervention: tripterygium wilfordii (TW) (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- The percentage of total effect of the 3 groups and adverse event within the follow-up periods.(12 months)
Investigators
Zhi-Hong Liu, M.D.
professor
Nanjing University School of Medicine
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