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

Not Applicable

Completed

• Conditions: Idiopathic Membranous Nephropathy
• Interventions: Drug: Tripterygium wilfordii; Drug: FK506

• Registration Number: NCT01161459
• Lead Sponsor: Zhi-Hong Liu, M.D.

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 .

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-07-12
• Study First Submitted QC: 2010-07-12
• Study First Posted: 2010-07-13
• Primary Completion: 2012-04
• Study Completion: 2013-10
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-29
• Last Update Posted: 2014-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tripterygium wilfordii	Tripterygium wilfordii	120mg/d for 6 months,then decrease to 60mg/d by 30mg/d every month for 12 months
FK506	FK506	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine; 🇨🇳 Nanjing, Jiangsu, China