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

Not Applicable

Completed

• Conditions: Proteinuria; Focal Segmental Glomerulosclerosis
• Interventions: Drug: tripterygium wilfordii (TW)

• Registration Number: NCT00801463
• Lead Sponsor: Nanjing University School of Medicine

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.

Study Timeline

• Study First Submitted: 2008-12-02
• Study First Submitted QC: 2008-12-02
• Study First Posted: 2008-12-03
• Study Start: 2009-01
• Status Verified: 2009-04
• Primary Completion: 2011-01
• Study Completion: 2011-02
• Last Update Submitted: 2011-05-17
• Last Update Posted: 2011-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
small pred	tripterygium wilfordii (TW)	Pred 30mg/d\*8wks
Large pred	tripterygium wilfordii (TW)	Prednisone 60mg/d\*8 wks

Primary Outcome Measures

Name	Time	Method
To assess the efficacy and safety of TW in the treatment of FSGS	12 months

Trial Locations

Locations (1)

Research Institute of Nephrology, Jinling Hospital; 🇨🇳 Nanjing, Jiangsu, China