Treatment of Idiopathic Membranous Nephropathy With Tripterygium Wilfordii Plus Steroid vs Tacrolimus Plus Steroid
Primary Purpose
Idiopathic Membranous Nephropathy
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tripterygium wilfordii
FK506
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Membranous Nephropathy focused on measuring Idiopathic Membranous Nephropathy, Treatment, FK506, Tripterygium wilfordii
Eligibility Criteria
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
Sites / Locations
- Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tripterygium wilfordii
FK506
Arm Description
120mg/d for 6 months,then decrease to 60mg/d by 30mg/d every month for 12 months
Outcomes
Primary Outcome Measures
The number of CR and PR of Tripterygium wilfordii plus steroid in the treatment of membranous nephropathy
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01161459
Brief Title
Treatment of Idiopathic Membranous Nephropathy With Tripterygium Wilfordii Plus Steroid vs Tacrolimus Plus Steroid
Official Title
Research Institute of Nephrology, Jinling Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhi-Hong Liu, M.D.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Membranous Nephropathy
Keywords
Idiopathic Membranous Nephropathy, Treatment, FK506, Tripterygium wilfordii
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tripterygium wilfordii
Arm Type
Experimental
Arm Description
120mg/d for 6 months,then decrease to 60mg/d by 30mg/d every month for 12 months
Arm Title
FK506
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tripterygium wilfordii
Other Intervention Name(s)
TW
Intervention Description
Tripterygium wilfordii 120mg/d Prednisone 30mg/d
Intervention Type
Drug
Intervention Name(s)
FK506
Other Intervention Name(s)
Tacrolimus + Prednisone 30mg/d
Intervention Description
capsule
Primary Outcome Measure Information:
Title
The number of CR and PR of Tripterygium wilfordii plus steroid in the treatment of membranous nephropathy
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerabilitysteroid
Description
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhihong Liu, Master
Organizational Affiliation
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
12. IPD Sharing Statement
Learn more about this trial
Treatment of Idiopathic Membranous Nephropathy With Tripterygium Wilfordii Plus Steroid vs Tacrolimus Plus Steroid
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