Tacrolimus Treatment of Patients With Idiopathic Focal Segmental Glomerulosclerosis

Focal Glomerulosclerosis Clinical Trial

Official title:

Tacrolimus Treatment of Patients With Idiopathic Focal Segmental

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00302536
• Other study ID #: NJCT-0604
• Status: Withdrawn
• Phase: N/A
• First received: March 13, 2006
• Last updated: February 8, 2012
• Start date: March 2006
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 50 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Focal Glomerulosclerosis
• Glomerulosclerosis, Focal Segmental

Intervention

Drug:
• Tacrolimus
Tacrolimus

Locations

Country	Name	City	State
China	Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the efficacy of Tacrolimus Treatment Idiopathic Focal Segmental Glomerulosclerosis		18 months	Yes
Secondary	To investigate the safety and tolerability of Tacrolimus vs Steroids in Treatment Idiopathic Focal Segmental Glomerulosclerosis		18 months	Yes