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

Membranous Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00518219
• Other study ID #: NJCT-0702
• Status: Completed
• Phase: Phase 4
• First received: August 16, 2007
• Last updated: May 25, 2010
• Start date: July 2007
• Est. completion date: September 2009

Study information

• Verified date: March 2009
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy of TW compared to Valsartan in treatment of heavy proteinuria of membranous nephropathy.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: September 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, Membranous
• Kidney Diseases
• Membranous Nephropathy

Intervention

Drug:
• TW
TW,120mg/d

Locations

Country	Name	City	State
China	Research Institute of Nephrology	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of membranous nephropathy		12 months	Yes
Secondary	To investigate the safety and tolerability of TW vs ARB in treatment of MN		12 months	Yes