Corticosteroids in the Maintenance Therapy of Proliferative Lupus Nephritis: a Randomized Pilot Study
Overview
- Phase
- Phase 3
- Intervention
- prednisolone
- Conditions
- Lupus Nephritis
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Feasibility (recruitment rate and protocol adherence)
- Status
- Withdrawn
- Last Updated
- 17 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
1
Long-term low-dose prednisolone (5 - 7.5 mg/day)
Intervention: prednisolone
2
Intervention: Placebo
Outcomes
Primary Outcomes
Feasibility (recruitment rate and protocol adherence)
Time Frame: 12 months
Secondary Outcomes
- 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)