NCT00518362

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

May 27, 2010

Status Verified

April 1, 2009

Enrollment Period

2.2 years

First QC Date

August 16, 2007

Last Update Submit

May 25, 2010

Conditions

Diabetic Nephropathy

Keywords

TWValsartantreatmentdiabetic nephropathyProteinuria

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (1)

  • 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

Study Arms (1)

immunosuppressor

EXPERIMENTAL

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

Drug: TW

Interventions

TWDRUG

TW,120 mg/d

immunosuppressor

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institute of Nephrology

Nanjing, Jiangsu, 210002, China

Location

Related Publications (1)

  • 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.

    PMID: 23725518DERIVED

MeSH Terms

Conditions

Diabetic NephropathiesProteinuria

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Zhihong Liu, Master

    Jinling Hospital, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 16, 2007

First Posted

August 20, 2007

Study Start

July 1, 2007

Primary Completion

September 1, 2009

Study Completion

March 1, 2010

Last Updated

May 27, 2010

Record last verified: 2009-04

Locations

CN(1)