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

This study has been completed.
Sponsor:
Information provided by:
Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT00801463
First received: December 2, 2008
Last updated: May 17, 2011
Last verified: April 2009
History of Changes
  Purpose

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


Condition Intervention
Proteinuria
Focal Segmental Glomerulosclerosis
 Drug: tripterygium wilfordii (TW)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prednisone Plus Tripterygium Wilfordii Treatment of Adult Patients With Idiopathic Focal Segmental Glomerulosclerosis

Resource links provided by NLM:

MedlinePlus related topics: Steroids
Drug Information available for: Prednisone
U.S. FDA Resources

Further study details as provided by Nanjing University School of Medicine:

Primary Outcome Measures:
  • To assess the efficacy and safety of TW in the treatment of FSGS [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 67
Study Start Date: January 2009
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00801463

Locations
China, Jiangsu
Research Institute of Nephrology, Jinling Hospital
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Nanjing University School of Medicine
Investigators
Principal Investigator: Zhi-hong Liu, M.D Research Institute of Nephrology, Jinling Hospital,
  More Information

No publications provided

Responsible Party: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Research Institute of Nephrology, Jinling Hospital
ClinicalTrials.gov Identifier: NCT00801463     History of Changes
Other Study ID Numbers: NJCT-0801
Study First Received: December 2, 2008
Last Updated: May 17, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Nanjing University School of Medicine:
Focal Segmental Glomerulosclerosis
Prednisone
Tripterygium Wilfordii

Additional relevant MeSH terms:
Glomerulosclerosis, Focal Segmental
Proteinuria
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Prednisone
 Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 21, 2013