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

Proteinuria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00801463
• Other study ID #: NJCT-0801
• Status: Completed
• Phase: N/A
• First received: December 2, 2008
• Last updated: May 17, 2011
• Start date: January 2009
• Est. completion date: February 2011

Study information

• Verified date: April 2009
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Focal Segmental Glomerulosclerosis
• Glomerulosclerosis, Focal Segmental
• Proteinuria

Intervention

Drug:
• tripterygium wilfordii (TW)
Pre 30mg/d +TW 120 mg/d, po for 12 weeks

Locations

Country	Name	City	State
China	Research Institute of Nephrology, Jinling Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the efficacy and safety of TW in the treatment of FSGS		12 months	Yes