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

Sponsor

Nanjing University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT00518362

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Diabetic Nephropathy	Drug: TW	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

67 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2007

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: immunosuppressor Valsartan,160mg/d,TW 120mg/d	Drug: TW TW,120 mg/d

Arm

Intervention/Treatment

Experimental: immunosuppressor

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

Drug: TW

TW,120 mg/d

Outcome Measures

Primary Outcome Measures

To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of diabetic nephropathy [6 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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