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NCT Number: NCT00518362

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

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

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Key information

Conditions

Diabetic Nephropathy Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Institute of Nephrology

Nanjing, Jiangsu, 210002, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TW

Drug

TW,120 mg/d

Primary outcomes

  1. To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of diabetic nephropathy

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Nanjing University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Aug 20, 2007
Registry last updated
May 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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