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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00518362

Enrollment

Registered

2007-08-20

Start date

2007-07-31

Completion date

2010-03-31

Last updated

2010-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy

Keywords

TW, Valsartan, treatment, diabetic nephropathy, Proteinuria

Brief summary

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

Detailed 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.

Interventions

DRUGTW

TW,120 mg/d

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of diabetic nephropathy	6 months

Secondary

Measure	Time frame
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026