Liu 2006.

Trial name or title	Tacrolimus treatment of patients with idiopathic focal segmental glomerulosclerosis
Methods	Treatment, randomized, open label, active control, parallel assignment, safety/efficacy study
Participants	Age: 15 to 50 years Gender: Both 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/24 h 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.
Interventions	Tracrolimus versus steroids
Outcomes	Primary outcome measures: To assess the efficacy of tacrolimus treatment idiopathic focal segmental glomerulosclerosis [time frame:18 months].  Secondary outcome measures: To investigate the safety and tolerability of tacrolimus vs steroids in treatment idiopathic focal segmental glomerulosclerosis [time frame: 18 months].
Starting date	March 2006
Contact information	Shijun Li, M.D. Tel: +86 25 80860469 email: lsj8855@yahoo.com.cn
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