Status:
COMPLETED
Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Lupus Nephritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Glomerulonephritis is one of the major disease manifestations of systemic lupus erythematosus (SLE). Around one-third of the patients, however, do not respond to conventional immunosuppressive therapy...
Eligibility Criteria
Inclusion
- Age over 18 with informed consent.
- Fulfill the revised American College of Rheumatology criteria for SLE
- Biopsy-proven class III, IV, or V lupus nephritis within the past 24 months.
- Could not achieve complete remission after at least 4 months of conventional therapy (oral steroid plus cyclosphosphamide or mycophenolate mofetil).
- NB. Complete response is defined as proteinuria less than 0.5 g/day, with normal urinary sediment, a normal serum albumin concentration, and serum creatinine \<15% above the base-line value.
- Female patients of child-bearing age and male patients agree to maintain effective birth control practice during the study.
Exclusion
- Abnormal liver function tests
- Hepatitis B surface antigen or hepatitis C antibody positive
- Diabetic
- Receiving NSAID or other agents known to influence urinary
- Protein excretion
- Allergic or intolerant to macrolide antibiotics or tacrolimus
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01206569
Start Date
September 1 2010
End Date
February 1 2012
Last Update
December 4 2012
Active Locations (1)
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1
Prince of Wales Hospital
Shatin, Hong Kong