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Clinical Trials/NCT00885547
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:
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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 OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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 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

Sponsor
Nanjing University School of Medicine
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zhi-Hong Liu, M.D.

professor

Nanjing University School of Medicine

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Prospective Study of TW in Treatment of... | Clinical Trial