Clinical Trial: Steroids in the Maintenance of Remission of Proliferative Lupus Nephritis

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Corticosteroids in the Maintenance Therapy of Proliferative Lupus Nephritis: a Randomized Pilot Study

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 Summary:
Sponsor: Cambridge University Hospitals NHS Foundation Trust

Current Primary Outcome: Feasibility (recruitment rate and protocol adherence) [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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 ]

Original Secondary Outcome: Same as current

Information By: Cambridge University Hospitals NHS Foundation Trust

Dates:
Date Received: October 4, 2007
Date Started:
Date Completion:
Last Updated: May 28, 2008
Last Verified: May 2008