Tacrolimus Treatment of Patients With Idiopathic Focal Segmental Glomerulosclerosis
Information source: Nanjing University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Focal Glomerulosclerosis
Intervention: Tacrolimus (Drug)
Phase: N/A
Status: Withdrawn
Sponsored by: Nanjing University School of Medicine Official(s) and/or principal investigator(s): Zhi-hong Liu, M.D., Study Director, Affiliation: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Summary
The purpose of this study is to assess the efficacy of Tacrolimus Treatment of patients with
idiopathic focal segmental glomerulosclerosis.
Clinical Details
Official title: Tacrolimus Treatment of Patients With Idiopathic Focal Segmental
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To assess the efficacy of Tacrolimus Treatment Idiopathic Focal Segmental Glomerulosclerosis
Secondary outcome: To investigate the safety and tolerability of Tacrolimus vs Steroids in Treatment 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.
Eligibility
Minimum age: 15 Years.
Maximum age: 50 Years.
Gender(s): Both.
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
Locations and Contacts
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, Jiangsu 210002, China
Additional Information
Starting date: March 2006
Last updated: February 8, 2012
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