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The purpose of this study is to compare the efficacy and safety of Tripterygium (TW) versus Valsartan (ARB) in the Diabetic Nephropathy (DN).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immunosuppressor | Experimental | Valsartan,160mg/d,TW 120mg/d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TW | Drug | TW,120 mg/d |
|
| Measure | Description | Time Frame |
|---|---|---|
| To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of diabetic nephropathy | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhihong Liu, Master | Jinling Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute of Nephrology | Nanjing | Jiangsu | 210002 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23725518 | Derived | Ge Y, Xie H, Li S, Jin B, Hou J, Zhang H, Shi M, Liu Z. Treatment of diabetic nephropathy with Tripterygium wilfordii Hook F extract: a prospective, randomized, controlled clinical trial. J Transl Med. 2013 May 31;11:134. doi: 10.1186/1479-5876-11-134. |
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |