To Compare the Efficacy and Safety of Tripterygium (TW) Versus Valsartan in the Diabetic Nephropathy (DN)

Diabetic Nephropathy Clinical Trial

Official title:

To Compare the Efficacy and Safety of TW vs Valsartan in the DN

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00518362
• Other study ID #: NJCT-0701
• Status: Completed
• Phase: N/A
• First received: August 16, 2007
• Last updated: May 25, 2010
• Start date: July 2007
• Est. completion date: March 2010

Study information

• Verified date: April 2009
• 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 compare the efficacy and safety of Tripterygium (TW) versus Valsartan (ARB) in the Diabetic Nephropathy (DN).

Description:

Diabetic nephropathy with heavy proteinuria have high risks of progressing to end stage renal disease. Though recent studies have shown that ACEI or ARB could reduce proteinuria of DN and slowed the progression to ESRD. But ARBs can only reduce proteinuria about 30%, so some patients still have heavy proteinuria,and then loss their renal function rapidly. So, to reduce the proteinuria of DN is a very important therapy target.

Tripterygium (TW) is a Chinese traditional patent drug, it can reduce proteinuria of chronic glomerular nephritis. So, we designed this randomized, prospective clinical trial to assess the efficacy and safety of TW versus ARB in the treatment of heavy proteinuria of DN.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: March 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

Inclusion Criteria:

1. A new diagnosis of diabetic nephropathy proved by histology and(or) serology.

2. Proteinuria > 2.5 g/24 h

3. serum creatinine < 3 mg/dl

4. age 35-65 years

Exclusion Criteria:

1. Co-existence of anther chronic glomerular nephritis.

2. Severe disfunction of the liver

3. White blood cell < 3000/ul

4. Severe infection in the past 1 month

5. Malignant hypertension which in hard to control

6. Myocardial infarct or heart failure or sever cerebral vessels complication in the past 6 month

Study Design

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

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Drug:
• TW
TW,120 mg/d

Locations

Country	Name	City	State
China	Research Institute of Nephrology	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of diabetic nephropathy		6 months	Yes
Secondary	To investigate the safety and tolerability of TW vs ARB. To access whether TW can delay the progression to ESRD or creatinine-doubling in diabetic nephropathy with heavy proteinuria.		6 months	Yes