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

May 17, 2011 updated by: Nanjing University School of Medicine
The purpose of this study is to assess the efficacy of prednisone and tripterygium wilfordii in treated Focal Segmental Glomerulosclerosis (FSGS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Research Institute of Nephrology, Jinling Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • tripterygium wilfordii

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the efficacy and safety of TW in the treatment of FSGS
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing University School of Medicine

Investigators

  • Principal Investigator: Zhi-hong Liu, M.D, Research Institute of Nephrology, Jinling Hospital,

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

December 2, 2008

First Submitted That Met QC Criteria

December 2, 2008

First Posted (Estimate)

December 3, 2008

Study Record Updates

Last Update Posted (Estimate)

May 18, 2011

Last Update Submitted That Met QC Criteria

May 17, 2011

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NJCT-0801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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