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

Nanjing University School of Medicine

Status

Completed

Conditions

Proteinuria

Focal Segmental Glomerulosclerosis

Treatments

Drug: tripterygium wilfordii (TW)

Study type

Interventional

Funder types

Other

Identifiers

NCT00801463

NJCT-0801

Details and patient eligibility

About

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

Full 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.

Enrollment

67 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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