Lupus Nephritis
Conditions
Keywords
systemic lupus erythematosus, lupus nephritis
Brief summary
There is debate as to whether long-term low-dose steroids such as prednisolone help to suppress relapses of systemic lupus erythematosus (SLE) in patients who are in remission from their lupus nephritis. If low-dose prednisolone reduces relapses, these beneficial effects may be counter-balanced by the long-term side-effects associated with prednisolone. This pilot study will determine the feasibility of conducting a larger randomized control trial that will answer the question of whether or not long-term low-dose prednisolone (5 - 7.5 mg/day) reduces the flares of SLE in patients with previous lupus nephritis.
Interventions
DRUGprednisolone
5 - 7.5 mg/day
DRUGPlacebo
Matched placebo to prednisolone
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age at least 18 years * diagnosis of SLE by ACR criteria * diagnosis of proliferative lupus nephritis (ISN/RPS class III or IV) * currently on prednisolone (5 to 20 mg/day) * in partial or complete remission for at least 3 months
Exclusion criteria
* currently pregnant * in end-stage renal failure * receiving corticosteroids for an indication other than lupus nephritis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility (recruitment rate and protocol adherence) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 1) time to major renal and non-renal relapses of SLE 2) time to minor relapses of SLE 3) health related quality of life 4) adverse events/side-effects 5) accrual of SLE related organ damage 6) renal function | 24 months |
Countries
United Kingdom
Outcome results
None listed