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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-02-28

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).

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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.

Conditions

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Proteinuria Focal Segmental Glomerulosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Large pred

Prednisone 60mg/d\*8 wks

Group Type EXPERIMENTAL

tripterygium wilfordii (TW)

Intervention Type DRUG

Pre 30mg/d +TW 120 mg/d, po for 12 weeks

small pred

Pred 30mg/d\*8wks

Group Type EXPERIMENTAL

tripterygium wilfordii (TW)

Intervention Type DRUG

Pre 30mg/d +TW 120 mg/d, po for 12 weeks

Interventions

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tripterygium wilfordii (TW)

Pre 30mg/d +TW 120 mg/d, po for 12 weeks

Intervention Type DRUG

Other Intervention Names

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tripterygium wilfordii

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No