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

This is an interventional supportive care trial for Systemic Lupus Erythematosus (SLE) focused on measuring Lupus, SLE Read More

Inclusion Criteria:

1. Male or female aged at least 18 years old.
2. Capable of giving written consent on an Institutional Review Board or IRB-approved Informed Consent Form prior to any study-specific evaluation
3. Have a clinical diagnosis of SLE with at least 4 of the 11 American College of Rheumatology (ACR) criteria as modified in 1997 or meeting SLICC criteria
4. SLE activity (SLEDAI ≥6)

5. On a stable SLE treatment regimen consisting of a stable dosage of any of the following medications for a period of at least 30 days prior to Baseline (i.e., day of 1st dose of study agent):

   1. Corticosteroids. Corticosteroids (< 20 mg prednisone or equivalent per day)
   2. Hydroxychloroquine or equivalent anti-malarial
   3. Other immunosuppressive or immunomodulatory agents including methotrexate, azathioprine, leflunomide, mycophenolate (including mycophenolate mofetil, mycophenolate mofetil hydrochloride, and mycophenolate sodium at no more than 2 grams/day), calcineurin inhibitors (e.g., tacrolimus,cyclosporine)
   4. Belimumab dose must be stable for 60 days prior to Baseline
   5. Cyclophosphamide dose must be stable for the last 90 days prior to Baseline
   6. Have not received rituximab within 6 months
6. Have a low habitual consumption of fatty fish and seafood, defined as a frequency of twice per month or less; see Addendum 1 for a list of fish and seafood considered to be fatty.

Exclusion Criteria:

Patients are excluded from the study if any of the following criteria are met:

1. Have rapidly progressive neurologic or renal disease
2. Currently taking an omega-3 prescription drug (e.g. Lovaza®, Vascepa®, etc.) or as medical food (e.g. Vascazen®, Vayarin, Onemia™etc.)
3. Present or recent use (within 3 months of screening) of any OTC fish or krill oil dietary supplement., or any long-chain omega-3 fatty acid dietary supplement (e.g.,MegaRed)
4. Have severe lupus kidney disease (defined by proteinuria > 6 gm/24 hour or equivalent using spot urine protein to creatinine ratio, or serum creatinine > 2.5mg/dL)
5. Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not related to SLE (i.e., diabetes, cardiovascular, pulmonary, hematologic, gastrointestinal, neurological, or infectious) which, in the opinion of the treating physician, could confound the results of the study or put the patients at undue risk
6. Have received intravenous glucocorticoids at a dosage of ≥ 500 mg daily within the past month
7. Require anti-coagulation with coumadin, clopidogrel, dalteparin, dypyridamole, enoxaparin, heparin or ticlopidine. Low dose aspirin (<325 mg/day) is permitted.
8. Receiving orlistat (Xenical, Alli) and have refused to discontinue at baseline and throughout the trial.
9. History of allergy to seafood or shellfish
10. Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Baseline
11. Are pregnant or lactating
12. Recent participation in a clinical trial with an experimental agent in the past 6 weeks, or 5 half-lives of the study drug, whichever is longer

13. Have a Grade 3 or greater laboratory abnormality based on the Adverse Event Severity Grading Tables (CTCAE), except for the following that are allowed:

    1. Stable Grade 3 partial thromboplastin time (PTT) due to lupus anticoagulant and not related to liver disease or anti-coagulant therapy
    2. Stable Grade 3 hypoalbuminemia due to chronic lupus nephritis, and not related to liver disease
    3. Stable Grade 3 gamma glutamyl transferase (GGT) elevation due to lupus hepatitis, and not related to alcoholic liver disease, uncontrolled diabetes, or viral hepatitis. If present, any abnormalities in the ALT or Alanine Transaminase and/or AST or Aspartate Transaminase must be < Grade 2.
    4. Stable Grade 3 neutropenia or stable Grade 3 white blood cell count due to lupus.

14. Patients will be excluded from the study based on the following bone marrow, hepatic and renal function values:

    1. Hemoglobin: < 8.0 gm/dL
    2. Platelets: <50,000/mm
    3. ANC < 1.0 x 103/mm
    4. AST or ALT >2.5 x Upper Limit of Normal unless related to primary disease.
    5. Creatinine clearance ≤ 25ml/min per 1.73m2