Clinical trial NCT00801463: Prednisone Plus Tripterygium Wilfordii Treatment of Adult Patients With Idiopathic Focal Segmental Glomerulosclerosis
Official title: Prednisone Plus Tripterygium Wilfordii Treatment of Adult Patients With Idiopathic Focal Segmental Glomerulosclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proteinuria
Focal Segmental Glomerulosclerosis
Keywords: Focal Segmental Glomerulosclerosis
Prednisone
Tripterygium Wilfordii
Lead sponsor: Nanjing University School of Medicine
Sponsor class: OTHER
First posted: 2008-12-03
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: To assess the efficacy and safety of TW in the treatment of FSGS
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Research Institute of Nephrology, Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Research Institute of Nephrology, Jinling Hospital,
name: Zhi-hong Liu, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.