Status:
COMPLETED
Tacrolimus Treatment of Patients With Idiopathic Membranous Nephropathy
Lead Sponsor:
Nanjing University School of Medicine
Conditions:
Idiopathic Membranous Nephropathy
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The purpose of this study is: * To explore the potential role of tacrolimus in the treatment of membranous nephropathy. * To investigate the safety and tolerability of tacrolimus vs methylprednisolon...
Detailed Description
Idiopathic membranous nephropathy is the most common cause of nephrotic syndrome in adults. Over the past decade, a number of studies have reported therapeutic efficacy for treatment with Cyclosporine...
Eligibility Criteria
Inclusion
- Biopsy-proven idiopathic membranous nephropathy
- Nephrotic syndrome with proteinuria ( \> 4 g/day) and serum albumin \< 30 g/dl
- Age 18-60 years with informed consent
Exclusion
- Patient with abnormal liver function tests
- Prior therapy with sirolimus, CSA, MMF, or azathioprin, cytoxan, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days
- Active/serious infection
- Patient with hepatitis B surface antigen or who is hepatitis C antibody positive
- Patient who is diabetic
- Patient is allergic or intolerant to macrolide antibiotics or tacrolimus
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00302523
Start Date
March 1 2006
End Date
December 1 2009
Last Update
February 3 2012
Active Locations (2)
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1
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, China, 210002
2
Research Institute of Nephrology, Jinling Hospital
Nanjing, Jiangsu, China, 210002