Tacrolimus Treatment of Patients With Idiopathic Focal Segmental Glomerulosclerosis

Not Applicable

Withdrawn

• Conditions: Focal Glomerulosclerosis
• Interventions: Drug: Tacrolimus

• Registration Number: NCT00302536
• Lead Sponsor: Nanjing University School of Medicine

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-13
• Study First Submitted QC: 2006-03-13
• Study First Posted: 2006-03-14
• Primary Completion: 2010-05
• Status Verified: 2010-09
• Study Completion: 2010-09
• Last Update Submitted: 2012-02-08
• Last Update Posted: 2012-02-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tacrolimus	Tacrolimus	-

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of Tacrolimus Treatment Idiopathic Focal Segmental Glomerulosclerosis	18 months

Secondary Outcome Measures

Name	Time	Method
To investigate the safety and tolerability of Tacrolimus vs Steroids in Treatment Idiopathic Focal Segmental Glomerulosclerosis	18 months

Trial Locations

Locations (1)

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine; 🇨🇳 Nanjing, Jiangsu, China