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Tacrolimus Treatment of Patients With Idiopathic Focal Segmental Glomerulosclerosis

This study has been withdrawn prior to enrollment.
(There was less patients recruited.)
Sponsor:
Information provided by:
Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT00302536
First received: March 13, 2006
Last updated: February 8, 2012
Last verified: September 2010
History of Changes
  Purpose

The purpose of this study is to assess the efficacy of Tacrolimus Treatment of patients with idiopathic focal segmental glomerulosclerosis.


Condition Intervention
Focal Glomerulosclerosis
 Drug: Tacrolimus

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tacrolimus Treatment of Patients With Idiopathic Focal Segmental

Resource links provided by NLM:

Drug Information available for: Tacrolimus
U.S. FDA Resources

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

Primary Outcome Measures:
  • To assess the efficacy of Tacrolimus Treatment Idiopathic Focal Segmental Glomerulosclerosis [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To investigate the safety and tolerability of Tacrolimus vs Steroids in Treatment Idiopathic Focal Segmental Glomerulosclerosis [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: March 2006
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tacrolimus Drug: Tacrolimus
Tacrolimus
Other Name: Tacrolimus, Prograf

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 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.

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00302536

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

No publications provided

Responsible Party: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT00302536     History of Changes
Other Study ID Numbers: NJCT-0604
Study First Received: March 13, 2006
Last Updated: February 8, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Nanjing University School of Medicine:
Idiopathic Focal Segmental Glomerulosclerosis
Treatment
Steroids

Additional relevant MeSH terms:
Glomerulosclerosis, Focal Segmental
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases
 Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013