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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00801463
Recruitment Status : Completed
First Posted : December 3, 2008
Last Update Posted : May 18, 2011
Sponsor:
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Proteinuria Focal Segmental Glomerulosclerosis Drug: tripterygium wilfordii (TW) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prednisone Plus Tripterygium Wilfordii Treatment of Adult Patients With Idiopathic Focal Segmental Glomerulosclerosis
Study Start Date : January 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
Drug Information available for: Prednisone

Arm Intervention/treatment
Experimental: Large pred
Prednisone 60mg/d*8 wks
Drug: tripterygium wilfordii (TW)
Pre 30mg/d +TW 120 mg/d, po for 12 weeks
Other Name: tripterygium wilfordii

Experimental: small pred
Pred 30mg/d*8wks
Drug: tripterygium wilfordii (TW)
Pre 30mg/d +TW 120 mg/d, po for 12 weeks
Other Name: tripterygium wilfordii




Primary Outcome Measures :
  1. To assess the efficacy and safety of TW in the treatment of FSGS [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00801463


Locations
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China, Jiangsu
Research Institute of Nephrology, Jinling Hospital
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Nanjing University School of Medicine
Investigators
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Principal Investigator: Zhi-hong Liu, M.D Research Institute of Nephrology, Jinling Hospital,
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Responsible Party: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Research Institute of Nephrology, Jinling Hospital
ClinicalTrials.gov Identifier: NCT00801463    
Other Study ID Numbers: NJCT-0801
First Posted: December 3, 2008    Key Record Dates
Last Update Posted: May 18, 2011
Last Verified: April 2009
Keywords provided by Nanjing University School of Medicine:
Focal Segmental Glomerulosclerosis
Prednisone
Tripterygium Wilfordii
Additional relevant MeSH terms:
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Proteinuria
Glomerulosclerosis, Focal Segmental
Urination Disorders
Urologic Diseases
Urological Manifestations
Glomerulonephritis
Nephritis
Kidney Diseases