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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00518362
Recruitment Status : Completed
First Posted : August 20, 2007
Last Update Posted : May 27, 2010
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Drug: TW Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : July 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Valsartan

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

Primary Outcome Measures :
  1. To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of diabetic nephropathy [ Time Frame: 6 months ]

Secondary Outcome Measures :
  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 ]

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00518362

China, Jiangsu
Research Institute of Nephrology
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Nanjing University School of Medicine
Principal Investigator: Zhihong Liu, Master Jinling Hospital, China

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing University School of Medicine Identifier: NCT00518362     History of Changes
Other Study ID Numbers: NJCT-0701
First Posted: August 20, 2007    Key Record Dates
Last Update Posted: May 27, 2010
Last Verified: April 2009

Keywords provided by Nanjing University School of Medicine:
diabetic nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action