Tacrolimus Treatment of Patients With Idiopathic Focal Segmental Glomerulosclerosis

• Status: Withdrawn
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Nanjing University School of Medicine
• Treatments: Tacrolimus

Criteria

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