Lupus Nephritis
Conditions
Keywords
lupus, nephritis, tacrolimus, mycophenolate mofetil
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 will be compared.
Interventions
DRUGtacrolimus
0.06-0.1 mg/kg/day
DRUGmycophenolate mofetil
2-3 gm/day
Sponsors
Tuen Mun Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who fulfill at least 4 of the ACR criteria for SLE 2. Age \>= 18 years 3. Biopsy proven active lupus glomerulonephritis (ISN/RPS class III/IV/V) 4. Serum creatinine \< 200 umol/L at the time of randomization
Exclusion criteria
1. Patients who refuse to be randomized for treatment 2. Patients who prefer treatment with conventional agents such as oral or intravenous CYC for various reasons 3. Serum creatinine \>= 200 umol/L at the time of randomization 4. Patients without renal biopsy or those who have lupus nephritis ISN/RPS class I,II,VI 5. Patients who are pregnant or plan for pregnancy within 12 months after randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| remission rate | month 6 |
Secondary
| Measure | Time frame |
|---|---|
| renal function deterioration, relapse and mortality | month 60 |
Countries
China
Outcome results
None listed