Status:
COMPLETED
Prednisone Plus Tripterygium Wilfordii Treatment of Adult Patients With Idiopathic Focal Segmental Glomerulosclerosis
Lead Sponsor:
Nanjing University School of Medicine
Conditions:
Proteinuria
Focal Segmental Glomerulosclerosis
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The purpose of this study is to assess the efficacy of prednisone and tripterygium wilfordii in treated Focal Segmental Glomerulosclerosis (FSGS).
Detailed Description
Primary FSGS is a leading cause of end stage renal disease in adults, with complete loss of kidney function in 50% of patients over 10 years. Steroids, which are currently used to treat the disease, a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00801463
Start Date
January 1 2009
End Date
February 1 2011
Last Update
May 18 2011
Active Locations (1)
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1
Research Institute of Nephrology, Jinling Hospital
Nanjing, Jiangsu, China, 210002