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

Nanjing University School of Medicine68 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Membranous Nephropathy

Interventions

TWDRUG

TW,120mg/d

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Institute of Nephrology

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

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

Time frame: 12 months

Data from ClinicalTrials.gov

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