Trial | NCT00518362  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    67
The purpose of this study is to compare the efficacy and safety of Tripterygium (TW) versus Valsartan (ARB) in the Diabetic Nephropathy (DN).
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.
Study Started
Jul 31
2007
Primary Completion
Sep 30
2009
Study Completion
Mar 31
2010
Last Update
May 27
2010
Estimate

Drug TW

TW,120 mg/d

immunosuppressor Experimental

Valsartan,160mg/d,TW 120mg/d

Criteria 

Inclusion Criteria:

A new diagnosis of diabetic nephropathy proved by histology and(or) serology.
Proteinuria > 2.5 g/24 h
serum creatinine < 3 mg/dl
age 35-65 years

Exclusion Criteria:

Co-existence of anther chronic glomerular nephritis.
Severe disfunction of the liver
White blood cell < 3000/ul
Severe infection in the past 1 month
Malignant hypertension which in hard to control
Myocardial infarct or heart failure or sever cerebral vessels complication in the past 6 month
No Results Posted