Steroids in the Maintenance of Remission of Proliferative Lupus Nephritis
NCT00539799 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2008-05-29
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.
Conditions
Interventions
- DRUG
-
prednisolone
5 - 7.5 mg/day
- DRUG
-
Matched placebo to prednisolone
Sponsors & Collaborators
-
Cambridge University Hospitals NHS Foundation Trust
lead OTHER
Principal Investigators
-
David Jayne, MD · Cambridge University Hospitals NHS Foundation Trust
-
Michael Walsh, MD · Cambridge University Hospitals NHS Foundation Trust
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- United Kingdom
Study Locations
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