Prednisone Plus Tripterygium Wilfordii Treatment of Adult Patients With Idiopathic Focal Segmental Glomerulosclerosis
1 other identifier
interventional
67
1 country
1
Brief Summary
The purpose of this study is to assess the efficacy of prednisone and tripterygium wilfordii in treated Focal Segmental Glomerulosclerosis (FSGS).
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 Jan 2009
Typical duration 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
First Submitted
Initial submission to the registry
December 2, 2008
CompletedFirst Posted
Study publicly available on registry
December 3, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedMay 18, 2011
April 1, 2009
2 years
December 2, 2008
May 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the efficacy and safety of TW in the treatment of FSGS
12 months
Study Arms (2)
Large pred
EXPERIMENTALPrednisone 60mg/d\*8 wks
small pred
EXPERIMENTALPred 30mg/d\*8wks
Interventions
Pre 30mg/d +TW 120 mg/d, po for 12 weeks
Eligibility Criteria
You may qualify if:
- Age 18-60 years at onset of signs or symptoms of FSGS
- Urine protein ≥ 3.5 g/24 h
- Estimated glomerular filtration rate (GFR) ≥ 40 ml/min/1.73 m2, serum creatinine\<2.5mg/dl
- Biopsy confirmed as idiopathic FSGS (including all subtypes)
- Willingness to follow the clinical trial protocol, including medications, and baseline and follow-up visits and procedures
You may not qualify if:
- Secondary FSGS
- Prior therapy with sirolimus, Cyclosporine, MMF, azathioprin, cytoxan, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days
- Active/serious infection
- Malignancy
- Previously diagnosed as diabetes mellitus type 1 or 2, or abnormal carbohydrate tolerance
- Peripheral white blood cells \< 3000/ul
- Clinical evidence of cirrhosis or chronic active liver diseases
- History of significant gastrointestinal disorder
- Allergy to study medications, and Inability to consent/assent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Institute of Nephrology, Jinling Hospital
Nanjing, Jiangsu, 210002, China
Related Publications (1)
Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.
PMID: 35224732DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhi-hong Liu, M.D
Research Institute of Nephrology, Jinling Hospital,
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 2, 2008
First Posted
December 3, 2008
Study Start
January 1, 2009
Primary Completion
January 1, 2011
Study Completion
February 1, 2011
Last Updated
May 18, 2011
Record last verified: 2009-04