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Completed

NCT Number: NCT00518219

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

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

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Key information

Conditions

Membranous Nephropathy Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, Membranous Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Institute of Nephrology

Nanjing, Jiangsu, 210002, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TW

Drug

TW,120mg/d

Other names: TW,Tripterygium wilfordii Hook.f

Primary outcomes

  1. To access the efficacy of TW compared to ARB in treatment of heavy proteinuria of membranous nephropathy

    Time frame: 12 months

Secondary outcomes

  1. To investigate the safety and tolerability of TW vs ARB in treatment of MN

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Nanjing University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 20, 2007
Registry last updated
May 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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