Status:
COMPLETED
Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous Nephritis
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Lupus Nephritis
Lupus Erythematosus, Systemic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The investigators study the efficacy and safety of tacrolimus in the treatment of membranous nephritis secondary to systemic lupus erythematosus.
Detailed Description
Glomerulonephritis is one of the major disease manifestations of systemic lupus erythematosus (SLE). The treatment of membranous (type V) lupus nephritis, a subset that carries a high morbidity, remai...
Eligibility Criteria
Inclusion
- Fulfill the revised American College of Rheumatology criteria for SLE
- Have biopsy-proven membranous nephropathy secondary to SLE
- Nephrotic syndrome with proteinuria (\> 3 g/day) and serum albumin \< 30 g/dl, with or without active urinary sediments despite steroid therapy (with or without cytotoxic agents)
- Age over 18 with informed consent
- Female patients of child-bearing age and male patients who agree to maintain effective birth control practice during the study
Exclusion
- Patient with abnormal liver function tests
- Patient with hepatitis B surface antigen or who is hepatitis C antibody positive
- Patient who is diabetic
- Patient who is receiving non-steroidal anti-inflammatory drugs (NSAIDs) or other agents known to influence urinary protein excretion
- Patient is allergic or intolerant to macrolide antibiotics or tacrolimus
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
February 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00125307
Start Date
January 1 2004
End Date
February 1 2008
Last Update
August 3 2015
Active Locations (1)
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1
Department of Medicine & Therapeutics, Prince of Wales Hospital
Shatin, Hong Kong