Focal Segmental Glomerulosclerosis, Proteinuria
Conditions
Keywords
Focal Segmental Glomerulosclerosis, Prednisone, Tripterygium Wilfordii
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, are effective in part of patients. Over the past decade, a number of studies have reported therapeutic efficacy for treatment with high-dose and over 6mo prednisone in patients with FSGS. These studies show that the total effective rates were only around 50%. But this therapy had taken some side effects of prednisone. Except these studies, in recent studies suggest that Tripterygium Wilfordii may be effective for passive Heymann nephritis, podocyte injury in nephrosis rats induced y puromycin aminonucleoside, and so on. FSGS is a podocytepathy. There was no-data of Prednisone and Tripterygium Wilfordii treatment of Chinese adult patients with idiopathic FSGS.
Interventions
Pre 30mg/d +TW 120 mg/d, po for 12 weeks
Sponsors
Nanjing University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy and safety of TW in the treatment of FSGS | 12 months |
Countries
China
Outcome results
None listed