Tacrolimus Treatment of Patients With Idiopathic Focal Segmental Glomerulosclerosis

Nanjing University School of Medicine

Status

Withdrawn

Conditions

Focal Glomerulosclerosis

Treatments

Drug: Tacrolimus

Study type

Interventional

Funder types

Other

Identifiers

NCT00302536

NJCT-0604

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

15 to 50 years old

Volunteers

Accepts Healthy Volunteers

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