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

IgA Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00885547
• Other study ID #: NJCT-0904
• Status: Terminated
• Phase: N/A
• First received: April 20, 2009
• Last updated: March 31, 2015
• Start date: March 2009
• Est. completion date: May 2011

Study information

• Verified date: March 2015
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy

Intervention

Drug:
• tripterygium wilfordii (TW)
90 mg/d for 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	The percentage of total effect of the 3 groups and adverse event within the follow-up periods.		12 months	Yes