Treatment of Idiopathic Membranous Nephropathy With Tripterygium Wilfordii Plus Steroid vs Tacrolimus Plus Steroid
Research Institute of Nephrology, Jinling Hospital
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 12, 2010
CompletedFirst Posted
Study publicly available on registry
July 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedJune 2, 2014
May 1, 2014
1.8 years
July 12, 2010
May 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The number of CR and PR of Tripterygium wilfordii plus steroid in the treatment of membranous nephropathy
18 months
Secondary Outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerabilitysteroid
18 months
Study Arms (2)
Tripterygium wilfordii
EXPERIMENTAL120mg/d for 6 months,then decrease to 60mg/d by 30mg/d every month for 12 months
FK506
ACTIVE COMPARATORInterventions
Tripterygium wilfordii 120mg/d Prednisone 30mg/d
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, 210002, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhihong Liu, Master
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
July 12, 2010
First Posted
July 13, 2010
Study Start
June 1, 2010
Primary Completion
April 1, 2012
Study Completion
October 1, 2013
Last Updated
June 2, 2014
Record last verified: 2014-05