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Omega-3 Replacement With Krill Oil in Disease Management of SLE

Research Question:
Does Krill Oil effectively replace omega-3 in patients with systemic lupus erythematosus?

Basic Study Information

Purpose:
A randomized, double-blind controlled, multicenter study in SLE patients given AKBM-3031 or placebo for 24 weeks (randomized period) and followed by an open label extension (OLE) treatment with AKBM-3031 for the next 24 weeks. Patients will be maintained on stable doses of background medications, except for glucocorticoids. Decreases in doses of glucocorticoids will be encouraged during the first 20 weeks of both the randomized and open label extension portions of the trial. Stable doses of glucocorticoids and other background medications are required during weeks 20-22 and 44-48. If indicated by the PI, brief increases in corticosteroids are permitted during the first 20 weeks of both the blinded and open label extension portion of the trial. The increase in prednisone (or equivalent) dose is limited to 2X the back-ground level to a maximum of 20 mg/day for a maximum of 1 week (7 days) or to a single administration of intravenous methylprednisolone or equivalent at a maximum dose of 500mg. Stable doses of glucocorticoids and other background medications are required during weeks 20-22 and 44-48

Location: University of Rochester Medical Center
Study Reference #: NA3

Lead Researcher (Principal Investigator)

Lead Researcher:  Jennifer Anolik, MD, PhD

Study Contact Information

Study Coordinator: Jennifer Anolik
Phone: (585) 275-1632
Email: jennifer_anolik@urmc.rochester.edu

Additional Study Details

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