IgA Nephropathy
Conditions
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).
Interventions
90 mg/d for 6 months
Sponsors
Nanjing University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage got to complete remission (CR) of TW group, the combined treatment group, and the control group after the 3, 6 months treatment. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of total effect of the 3 groups and adverse event within the follow-up periods. | 12 months |
Outcome results
None listed