Tacrolimus Treatment of Patients With Idiopathic Focal Segmental Glomerulosclerosis - Full Text View

Sponsored by:	Nanjing University School of Medicine
Information provided by:	Nanjing University School of Medicine
ClinicalTrials.gov Identifier:	NCT00302536

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

Drug Information available for: Tacrolimus Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Tacrolimus Treatment of Patients With Idiopathic Focal Segmental

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 ]

Estimated Enrollment:	40
Study Start Date:	March 2006
Estimated Study Completion Date:	December 2008
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Tacrolimus Tacrolimus,0.0mg/kg/d

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

Contacts

Contact: Shijun Li, M.D.

86-25-80860469

lsj8855@yahoo.com.cn

Locations

China, Jiangsu
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine	Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Shijun Li, M.D. 86-25-80860469 lsj8855@yahoo.com.cn
Principal Investigator: Zhi-hong Liu, M.D.

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

Responsible Party:	Nanjing University School of Medicine ( Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine )
Study ID Numbers:	NJCT-0604
Study First Received:	March 13, 2006
Last Updated:	July 25, 2008
ClinicalTrials.gov Identifier:	NCT00302536
Health Authority:	China: State Food and Drug Administration

Keywords provided by Nanjing University School of Medicine:

Idiopathic Focal Segmental Glomerulosclerosis
Treatment
Steroids

Study placed in the following topic categories:

Glomerulosclerosis, Focal Segmental
Glomerulonephritis
Urologic Diseases
Nephritis

Tacrolimus
Kidney Diseases
Focal segmental glomerulosclerosis

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009