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).
|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|
- 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 ]
- 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 ]
|Study Start Date:||July 2007|
|Study Completion Date:||March 2010|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Other Name: TW
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518362
|Research Institute of Nephrology|
|Nanjing, Jiangsu, China, 210002|
|Principal Investigator:||Zhihong Liu, Master||Jinling Hospital, China|