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

N

Nanjing University School of Medicine

Status and phase

Completed
Phase 4

Conditions

Membranous Nephropathy

Treatments

Drug: TW

Study type

Interventional

Funder types

Other

Identifiers

NCT00518219
NJCT-0702

Details and patient eligibility

About

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

Full 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.

Enrollment

68 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

68 participants in 1 patient group

immunosuppressor
Experimental group
Description:
TW 120mg/d,Valsartan,160mg/d
Treatment:
Drug: TW

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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