Lupus Nephritis
Conditions
Keywords
lupus, nephritis, glomerulonephritis, nephropathy, refractory
Brief summary
A trial of combination of two drugs for the treatment of refractory lupus nephritis.
Detailed description
Low-dose combination of mycophenolate mofetil and tacrolimus for refractory lupus nephritis: a 12-month prospective study
Interventions
DRUGlow dose combination of MMF and Tac
mycophenolate mofetil 500mg BID + tacrolimus 2mg BID
Sponsors
Tuen Mun Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Active nephritis documented by renal biopsy within 24 months of entry; 2. Failure to respond to 2 or more immunosuppressive regimens which consisted of high-dose prednisolone combined with other non-corticosteroid immunosuppressive agents together with ACE inhibitors plus or minus angiotensin receptor blockers (ARB) for at least 4 months for each regimen at the maximally tolerated drug dosages; 3. Serum creatinine (Scr) less than 200umol/L.
Exclusion criteria
1. Previous intolerance to either MMF/Tac; 2. Scr \>200umol/L; 3. Informed consent unavailable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission rate | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 12 months | adverse events experienced by patients as a measure of tolerability |
Countries
China
Outcome results
None listed