Steroids in the Maintenance of Remission of Proliferative Lupus Nephritis
- Registration Number
- NCT00539799
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 15
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo - 1 prednisolone Long-term low-dose prednisolone (5 - 7.5 mg/day)
- Primary Outcome Measures
Name Time Method Feasibility (recruitment rate and protocol adherence) 12 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Addenbrooke's Hospital
🇬🇧Cambridge, Cambridgeshire, United Kingdom