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

Nanjing University School of Medicine90 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

IgA Nephropathy

Interventions

tripterygium wilfordii (TW)DRUG

90 mg/d for 6 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

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.

Time frame: 12 months

Data from ClinicalTrials.gov

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