Tacrolimus Treatment of Patients With Idiopathic Focal Segmental Glomerulosclerosis

Tacrolimus Treatment of Patients With Idiopathic Focal Segmental

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00302536

Enrollment

Registered

2006-03-14

Start date

2006-03-31

Completion date

2010-09-30

Last updated

2012-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focal Glomerulosclerosis

Keywords

Idiopathic Focal Segmental Glomerulosclerosis, Treatment, Steroids

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.

Interventions

DRUGTacrolimus

Tacrolimus

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
To assess the efficacy of Tacrolimus Treatment Idiopathic Focal Segmental Glomerulosclerosis	18 months

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026