Clinical Trial: Tacrolimus Treatment of Patients With Idiopathic Focal Segmental Glomerulosclerosis

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Tacrolimus Treatment of Patients With Idiopathic Focal Segmental

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

Detailed Summary: 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.
Sponsor: Nanjing University School of Medicine

Current Primary Outcome: To assess the efficacy of Tacrolimus Treatment Idiopathic Focal Segmental Glomerulosclerosis [ Time Frame: 18 months ]

Original Primary Outcome: To assess the efficacy of Tacrolimus Treatment Idiopathic Focal Segmental Glomerulosclerosis

Current Secondary Outcome: To investigate the safety and tolerability of Tacrolimus vs Steroids in Treatment Idiopathic Focal Segmental Glomerulosclerosis [ Time Frame: 18 months ]

Original Secondary Outcome: To investigate the safety and tolerability of Tacrolimus vs Steroids in Treatment Idiopathic Focal Segmental Glomerulosclerosis .

Information By: Nanjing University School of Medicine

Dates:
Date Received: March 13, 2006
Date Started: March 2006
Date Completion: September 2010
Last Updated: February 8, 2012
Last Verified: September 2010