Status:
WITHDRAWN
Tacrolimus Treatment of Patients With Idiopathic Focal Segmental Glomerulosclerosis
Lead Sponsor:
Nanjing University School of Medicine
Conditions:
Focal Glomerulosclerosis
Eligibility:
All Genders
15-50 years
Phase:
NA
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, a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00302536
Start Date
March 1 2006
End Date
September 1 2010
Last Update
February 9 2012
Active Locations (1)
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1
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, China, 210002