A Phase 3 interventional study of prednisolone and Placebo in Lupus Nephritis, sponsored by Cambridge University Hospitals NHS Foundation Trust. Withdrawn at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-05-29.
Sponsored by Cambridge University Hospitals NHS Foundation Trust · Phase 3, Interventional, and Treatment
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.
245 studies on the registry are indexed under Nephritis; 56 are open to participants now.
This study's planned enrollment of 15 is below the median of 49 across 156 interventional studies indexed under Nephritis.
Browse Nephritis studies →Cambridge University Hospitals NHS Foundation Trust is the lead sponsor of 167 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Long-term low-dose prednisolone (5 - 7.5 mg/day)
Drug: prednisolone
Drug: Placebo
5 - 7.5 mg/day
Matched placebo to prednisolone
Feasibility (recruitment rate and protocol adherence)
Time frame: 12 months
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
Time frame: 24 months
This study is withdrawn, as verified in May 2008. You cannot join it, but the record below documents what was studied.
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Cambridge University Hospitals NHS Foundation Trust