Status:
COMPLETED
Comparing the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis
Lead Sponsor:
Tuen Mun Hospital
Conditions:
Lupus Nephritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is comparing the efficacy of tacrolimus and mycophenolate mofetil for the initial therapy of active lupus glomerulonephritis.
Detailed Description
Patients with biopsy proven active lupus nephritis will be randomized to receive tacrolimus or mycophenolate mofetil, on top of corticosteroids, for initial treatment. Efficacy and adverse effects wil...
Eligibility Criteria
Inclusion
- Patients who fulfill at least 4 of the ACR criteria for SLE
- Age \>= 18 years
- Biopsy proven active lupus glomerulonephritis (ISN/RPS class III/IV/V)
- Serum creatinine \< 200 umol/L at the time of randomization
Exclusion
- Patients who refuse to be randomized for treatment
- Patients who prefer treatment with conventional agents such as oral or intravenous CYC for various reasons
- Serum creatinine \>= 200 umol/L at the time of randomization
- Patients without renal biopsy or those who have lupus nephritis ISN/RPS class I,II,VI
- Patients who are pregnant or plan for pregnancy within 12 months after randomization
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00371319
Start Date
September 1 2005
End Date
June 1 2014
Last Update
July 2 2014
Active Locations (1)
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1
Tuen Mun Hospital
Hong Kong, China