Tacrolimus Treatment of Patients With Idiopathic Focal Segmental Glomerulosclerosis

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

Detailed Description
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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.

Official Title
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Tacrolimus Treatment of Patients With Idiopathic Focal Segmental

Conditions
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Focal Glomerulosclerosis

Intervention / Treatment
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* Drug: Tacrolimus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tacrolimus<br> | Drug: Tacrolimus<br>* Tacrolimus<br>* Other names: Tacrolimus, Prograf;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of Tacrolimus Treatment Idiopathic Focal Segmental Glomerulosclerosis |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the safety and tolerability of Tacrolimus vs Steroids in Treatment Idiopathic Focal Segmental Glomerulosclerosis |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Idiopathic Focal Segmental Glomerulosclerosis, Treatment, Steroids