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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00518219
Enrollment
68
Registered
2007-08-20
Start date
2007-07-31
Completion date
2009-09-30
Last updated
2010-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Membranous Nephropathy

Keywords

TW, Valsartan, treatment, membranous nephropathy, proteinuria

Brief summary

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

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.

Interventions

DRUGTW

TW,120mg/d

Sponsors

Nanjing University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frame
To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of membranous nephropathy12 months

Secondary

MeasureTime frame
To investigate the safety and tolerability of TW vs ARB in treatment of MN12 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026