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

Nanjing University School of Medicine

Status: Terminated

Conditions: IgA Nephropathy

Treatments: Drug: tripterygium wilfordii (TW)

Study type: Interventional

Funder types: Other

Identifiers

NCT00885547

NJCT-0904

Details and patient eligibility

About

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.

Full 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).

Enrollment: 90 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 1 patient group

immunosuppressor

Experimental group

Treatment:

Drug: tripterygium wilfordii (TW)