To Compare the Efficacy and Safety of Tripterygium (TW) Versus Valsartan in the Diabetic Nephropathy (DN)
Information source: Nanjing University School of Medicine
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Nephropathy
Intervention: Valsartan (Drug); TW (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Nanjing University School of Medicine Official(s) and/or principal investigator(s):
Zhihong Liu, Master, Principal Investigator, Affiliation: Jinling Hospital, China
Overall contact:
Zhihong Liu, Master, Phone: 086-025-80860218
Summary
The purpose of this study is to compare the efficacy and safety of Tripterygium (TW) versus
Valsartan (ARB) in the Diabetic Nephropathy (DN).
Clinical Details
Official title: To Compare the Efficacy and Safety of TW vs Valsartan in the DN
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of diabetic nephropathy
Secondary outcome: 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.
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
Minimum age: 35 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. A new diagnosis of diabetic nephropathy proved by histology and(or) serology.
2. Proteinuria > 3. 0 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
Locations and Contacts
Zhihong Liu, Master, Phone: 086-025-80860218
Research Institute of Nephrology, Nanjing, Jiangsu 210002, China; Recruiting
Yongchun Ge, bachelor, Phone: 086-025-80860469, Email: gyc_626828@hotmail.com.cn
Zhihong Liu, Master, Principal Investigator
Additional Information
Starting date: July 2007
Ending date: December 2009
Last updated: April 14, 2009
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