Treatment of Idiopathic Membranous Nephropathy With Tripterygium Wilfordii Plus Steroid vs Tacrolimus Plus Steroid

Research Institute of Nephrology, Jinling Hospital

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01161459

Enrollment

100

Registered

2010-07-13

Start date

2010-06-30

Completion date

2013-10-31

Last updated

2014-06-02

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

Conditions

Idiopathic Membranous Nephropathy

Keywords

Idiopathic Membranous Nephropathy, Treatment, FK506, Tripterygium wilfordii

Brief summary

The purpose of this study is: To explore the potential role of Tripterygium wilfordii plus steroid in the treatment of membranous nephropathy. To investigate the safety and tolerability of Tripterygium wilfordii plus steroid

Detailed description

Idiopathic membranous nephropathy is the most common cause of nephrotic syndrome in adults. Over the past decade, a number of studies have reported therapeutic efficacy for treatment with tacrolimus plus steroid in patients with nephrotic syndrome including patients with membranous nephropathy. This study will evaluate the safety and effectiveness of a traditional herbal extraction, Tripterygium wilfordii, plus steroid in reducing the amount of protein in the urine in patients with membranous nephropathy. A hundred patients with biopsy-proven membranous nephropathy will be recruited. They will be screened with a medical history, physical examination, blood tests, and an examination for infection, cancers, and other conditions that can cause membranous nephropathy. The investigators plan to conduct an open-label study of the efficacy and safety of Tripterygium wilfordii in the treatment of membranous nephropathy. Half of them will be treated with oral Tripterygium wilfordii plus steroids for 6 months, followed by 6 months of maintenance, and the other half treated with tacrolimus plus steroid as positive contrast. Proteinuria, renal function will be monitored. Complete remission is defined as 24-hour urinary protein excretion to less than 0.4 mg/day and serum albumin\>35g/L. This study will explore the potential role of Tripterygium wilfordii in the treatment of membranous nephropathy, it's cost less .

Interventions

DRUGTripterygium wilfordii

Tripterygium wilfordii 120mg/d Prednisone 30mg/d

DRUGFK506

capsule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Biopsy-proven idiopathic membranous nephropathy 2. Nephrotic syndrome with proteinuria ( \> 3.5 g/day) and serum albumin \< 30 g/dl 3. Age 18-65 years with informed consent

Exclusion criteria

1. Patient with elevated serum creatinine concentration 2. Prior therapy with sirolimus, CSA, MMF, or azathioprin, cytoxan, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days 3. Active/serious infection 4. Patient with hepatitis B surface antigen or who is hepatitis C antibody positive 5. Patient who is diabetic 6. Patient is allergic or intolerant to macrolide antibiotics or tacrolimus

Design outcomes

Primary

Measure	Time frame
The number of CR and PR of Tripterygium wilfordii plus steroid in the treatment of membranous nephropathy	18 months

Secondary

Measure	Time frame	Description
Number of Participants with Adverse Events as a Measure of Safety and Tolerabilitysteroid	18 months	Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Countries

China

Outcome results

None listed

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