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Tacrolimus Treatment of 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: NCT00302536
Recruitment Status : Withdrawn (There was less patients recruited.)
First Posted : March 14, 2006
Last Update Posted : February 9, 2012
Sponsor:
Information provided by:

March 13, 2006
March 14, 2006
February 9, 2012
March 2006
May 2010   (Final data collection date for primary outcome measure)
To assess the efficacy of Tacrolimus Treatment Idiopathic Focal Segmental Glomerulosclerosis [ Time Frame: 18 months ]
To assess the efficacy of Tacrolimus Treatment Idiopathic Focal Segmental Glomerulosclerosis
Complete list of historical versions of study NCT00302536 on ClinicalTrials.gov Archive Site
To investigate the safety and tolerability of Tacrolimus vs Steroids in Treatment Idiopathic Focal Segmental Glomerulosclerosis [ Time Frame: 18 months ]
To investigate the safety and tolerability of Tacrolimus vs Steroids in Treatment Idiopathic Focal Segmental Glomerulosclerosis .
Not Provided
Not Provided
 
Tacrolimus Treatment of Patients With Idiopathic Focal Segmental Glomerulosclerosis
Tacrolimus Treatment of Patients With Idiopathic Focal Segmental
The purpose of this study is to assess the efficacy of Tacrolimus Treatment of patients with idiopathic focal segmental glomerulosclerosis.
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 Cyclosporine-A (CSA) in patients with FSGS. Recent studies suggest that immunosuppressive therapy targeted against the calcineurin pathway of T-helper cells, for example, tacrolimus, may be effective in the treatment of primary FSGS. The experience with Tacrolimus (FK506) in the treatment of patients with FSGS has been limited to uncontrolled trials in adult patients.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Focal Glomerulosclerosis
Drug: Tacrolimus
Tacrolimus
Other Name: Tacrolimus, Prograf
Experimental: Tacrolimus
Intervention: Drug: Tacrolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2010
May 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 14-50 years at onset of signs or symptoms of FSGS
  • Biopsy proven FSGS
  • Estimated glomerular filtration rate (GFR) ≥ 40 ml/min/1.73 m2
  • Urine protein > 3.5 g/24h
  • Biopsy confirmed primary 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, CSA, MMF, or azathioprin, cytoxan, chlorambucil levamisole, methotrexate, or nitrogen mustard in the last 90 days
  • Active/serious infection
  • Malignancy
  • Previously diagnosed diabetes mellitus type 1 or 2
  • Clinical evidence of cirrhosis or chronic active liver disease
  • History of significant gastrointestinal disorder
  • Allergy to study medications, and Inability to consent/assent
Sexes Eligible for Study: All
15 Years to 50 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00302536
NJCT-0604
Yes
Not Provided
Not Provided
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing University School of Medicine
Nanjing University School of Medicine
Not Provided
Study Director: Zhi-hong Liu, M.D. Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing University School of Medicine
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP