Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

To Compare the Efficacy and Safety of Tripterygium Wilfordii (TW) Versus Valsartan in the Membranous Nephropathy (MN)

This study has been completed.
Information provided by:
Nanjing University School of Medicine Identifier:
First received: August 16, 2007
Last updated: May 25, 2010
Last verified: March 2009
The purpose of this study is to assess the efficacy of TW compared to Valsartan in treatment of heavy proteinuria of membranous nephropathy.

Condition Intervention Phase
Membranous Nephropathy
Drug: TW
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: To Compare the Efficacy and Safety of TW vs Valsartan in the MN

Resource links provided by NLM:

Further study details as provided by Nanjing University School of Medicine:

Primary Outcome Measures:
  • To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of membranous nephropathy [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • To investigate the safety and tolerability of TW vs ARB in treatment of MN [ Time Frame: 12 months ]

Enrollment: 68
Study Start Date: July 2007
Study Completion Date: September 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: immunosuppressor
TW 120mg/d,Valsartan,160mg/d
Drug: TW
Other Name: TW,Tripterygium wilfordii Hook.f

Detailed Description:

Membranous nephropathy with heavy proteinuria have high risks of progressing to CRF.

Tripterygium (TW) is a Chinese traditional patent drugs, it can reduce proteinuria of chronic glomerular nephritis,such as IgA nephropathy. So, we designed this randomized, prospective clinical trial to assess the efficacy and safety of TW versus Valsartan in the treatment of heavy proteinuria of MN.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Biopsy-proven idiopathic membranous nephropathy
  • Nephrotic syndrome with proteinuria (> 4 g/day) and serum albumin < 30 g/dl
  • Age over 18 with informed consent

Exclusion Criteria:

  • Patient with abnormal liver function tests
  • Prior therapy with sirolimus, CSA, MMF, tacrolimus or azathioprin, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days,
  • Active/serious infection,
  • Patient with hepatitis B surface antigen or who is hepatitis C antibody positive
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00518219

China, Jiangsu
Research Institute of Nephrology
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Nanjing University School of Medicine
Principal Investigator: Zhihong Liu, Master Jinling Hospital, China
  More Information

Responsible Party: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing University School of Medicine Identifier: NCT00518219     History of Changes
Other Study ID Numbers: NJCT-0702
Study First Received: August 16, 2007
Last Updated: May 25, 2010

Keywords provided by Nanjing University School of Medicine:
membranous nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Glomerulonephritis, Membranous
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017