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

This study has been completed.
Sponsor:
Information provided by:
Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT00518362
First received: August 16, 2007
Last updated: May 25, 2010
Last verified: April 2009
History of Changes
  Purpose

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


Condition Intervention
Diabetic Nephropathy
 Drug: TW

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: To Compare the Efficacy and Safety of TW vs Valsartan in the DN

Resource links provided by NLM:

Drug Information available for: Valsartan
U.S. FDA Resources

Further study details as provided by Nanjing University School of Medicine:

Primary Outcome Measures:
  • To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of diabetic nephropathy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 67
Study Start Date: July 2007
Study Completion Date: March 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: immunosuppressor
Valsartan,160mg/d,TW 120mg/d
 Drug: TW
TW,120 mg/d
Other Name: TW

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.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518362

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

No publications provided

Responsible Party: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT00518362     History of Changes
Other Study ID Numbers: NJCT-0701
Study First Received: August 16, 2007
Last Updated: May 25, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Nanjing University School of Medicine:
TW
Valsartan
treatment
diabetic nephropathy
Proteinuria

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

ClinicalTrials.gov processed this record on May 23, 2013