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

Primary Purpose

Diabetic Nephropathy

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

About this trial

This is an interventional treatment trial for Diabetic Nephropathy focused on measuring TW, Valsartan, treatment, diabetic nephropathy, Proteinuria

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A new diagnosis of diabetic nephropathy proved by histology and(or) serology.
Proteinuria > 2.5 g/24 h
serum creatinine < 3 mg/dl
age 35-65 years

Exclusion Criteria:

Co-existence of anther chronic glomerular nephritis.
Severe disfunction of the liver
White blood cell < 3000/ul
Severe infection in the past 1 month
Malignant hypertension which in hard to control
Myocardial infarct or heart failure or sever cerebral vessels complication in the past 6 month

Sites / Locations

Research Institute of Nephrology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

immunosuppressor

Arm Description

Valsartan,160mg/d,TW 120mg/d

Outcomes

Primary Outcome Measures

To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of diabetic nephropathy

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.

Full Information

NCT ID

NCT00518362

First Posted

August 16, 2007

Last Updated

May 25, 2010

Sponsor

Nanjing University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00518362

Brief Title

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

Official Title

To Compare the Efficacy and Safety of TW vs Valsartan in the DN

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Nanjing University School of Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Nephropathy

Keywords

TW, Valsartan, treatment, diabetic nephropathy, Proteinuria

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

immunosuppressor

Arm Type

Experimental

Arm Description

Valsartan,160mg/d,TW 120mg/d

Intervention Type

Drug

Intervention Name(s)

Intervention Description

TW,120 mg/d

Primary Outcome Measure Information:

Title

To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of diabetic nephropathy

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A new diagnosis of diabetic nephropathy proved by histology and(or) serology. Proteinuria > 2.5 g/24 h serum creatinine < 3 mg/dl age 35-65 years Exclusion Criteria: Co-existence of anther chronic glomerular nephritis. Severe disfunction of the liver White blood cell < 3000/ul Severe infection in the past 1 month Malignant hypertension which in hard to control Myocardial infarct or heart failure or sever cerebral vessels complication in the past 6 month

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhihong Liu, Master

Organizational Affiliation

Jinling Hospital, China

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Institute of Nephrology

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210002

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

23725518

Citation

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.

Results Reference

derived

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

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