Prednisone Plus Tripterygium Wilfordii Treatment of Adult Patients With Idiopathic Focal Segmental Glomerulosclerosis

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy of prednisone and tripterygium wilfordii in treated Focal Segmental Glomerulosclerosis (FSGS).

Detailed Description
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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.

Official Title
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Prednisone Plus Tripterygium Wilfordii Treatment of Adult Patients With Idiopathic Focal Segmental Glomerulosclerosis

Conditions
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Proteinuria, Focal Segmental Glomerulosclerosis

Intervention / Treatment
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* Drug: tripterygium wilfordii (TW)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Large pred<br>Prednisone 60mg/d*8 wks | Drug: tripterygium wilfordii (TW)<br>* Pre 30mg/d +TW 120 mg/d, po for 12 weeks<br>* Other names: tripterygium wilfordii;|
| Experimental: small pred<br>Pred 30mg/d*8wks | Drug: tripterygium wilfordii (TW)<br>* Pre 30mg/d +TW 120 mg/d, po for 12 weeks<br>* Other names: tripterygium wilfordii;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy and safety of TW in the treatment of FSGS |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Focal Segmental Glomerulosclerosis, Prednisone, Tripterygium Wilfordii