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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-10-31

Brief Summary

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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

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Detailed Description

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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 .

Conditions

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Idiopathic Membranous Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tripterygium wilfordii

120mg/d for 6 months,then decrease to 60mg/d by 30mg/d every month for 12 months

Group Type EXPERIMENTAL

Tripterygium wilfordii

Intervention Type DRUG

Tripterygium wilfordii 120mg/d Prednisone 30mg/d

FK506

Group Type ACTIVE_COMPARATOR

FK506

Intervention Type DRUG

capsule

Interventions

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Tripterygium wilfordii

Tripterygium wilfordii 120mg/d Prednisone 30mg/d

Intervention Type DRUG

FK506

capsule

Intervention Type DRUG

Other Intervention Names

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TW Tacrolimus + Prednisone 30mg/d

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No