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

Not Applicable

Completed

• Conditions: Diabetic Nephropathy
• Interventions: Drug: TW

• Registration Number: NCT00518362
• Lead Sponsor: Nanjing University School of Medicine

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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-08-16
• Study First Submitted QC: 2007-08-16
• Study First Posted: 2007-08-20
• Status Verified: 2009-04
• Primary Completion: 2009-09
• Study Completion: 2010-03
• Last Update Submitted: 2010-05-25
• Last Update Posted: 2010-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
immunosuppressor	TW	Valsartan,160mg/d,TW 120mg/d

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Institute of Nephrology; 🇨🇳 Nanjing, Jiangsu, China