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

Study Overview
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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

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 .

Official Title
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Research Institute of Nephrology, Jinling Hospital

Conditions
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Idiopathic Membranous Nephropathy

Intervention / Treatment
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* Drug: Tripterygium wilfordii
* Drug: FK506


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy-proven idiopathic membranous nephropathy Nephrotic syndrome with proteinuria ( > 3.5 g/day) and serum albumin < 30 g/dl Age 18-65 years with informed consent Exclusion Criteria: Patient with elevated serum creatinine concentration Prior therapy with sirolimus, CSA, MMF, or azathioprin, cytoxan, 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 Patient who is diabetic Patient is allergic or intolerant to macrolide antibiotics or tacrolimus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tripterygium wilfordii<br>120mg/d for 6 months,then decrease to 60mg/d by 30mg/d every month for 12 months | Drug: Tripterygium wilfordii<br>* Tripterygium wilfordii 120mg/d Prednisone 30mg/d<br>* Other names: TW;|
| Active Comparator: FK506<br> | Drug: FK506<br>* capsule<br>* Other names: Tacrolimus + Prednisone 30mg/d;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of CR and PR of Tripterygium wilfordii plus steroid in the treatment of membranous nephropathy |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerabilitysteroid | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Idiopathic Membranous Nephropathy, Treatment, FK506, Tripterygium wilfordii