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

Nanjing University School of Medicine

Status

Completed

Conditions

Diabetic Nephropathy

Treatments

Drug: TW

Study type

Interventional

Funder types

Other

Identifiers

NCT00518362

NJCT-0701

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and safety of Tripterygium (TW) versus Valsartan (ARB) in the Diabetic Nephropathy (DN).

Full 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.

Enrollment

67 patients

Sex

All

Ages

35 to 65 years old

Volunteers

No Healthy Volunteers

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