NCT03626311已完成不适用
A Double-Blind, Placebo-Controlled Randomized, Multicenter Study to Assess Changes in Omega-3 Index in Erythrocytes and Health Benefit After 24 Weeks of Daily Consumption of AKBM-3031 (Omega-3 Phospholipids From Krill), Followed by a 24 Week Open-Label Extension, in Patients With Systemic Lupus Erythematosus (SLE)
Aker BioMarine Human Ingredients AS35 个研究点 分布在 2 个国家目标入组 76 人开始时间: 2018年10月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 35
- 主要终点
- Difference in the ratio of omega-3 to omega-6 measured through lab tests on red blood cells from baseline through the end of the study in patients with generalized lupus.
研究概览
简要总结
A randomized, double-blind controlled, multicenter study in SLE patients given AKBM-3031or 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 of20 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged at least 18 years old.
- •Capable of giving written consent on an Institutional Review Board or IRB-approved Informed Consent Form prior to any study-specific evaluation
- •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
- •SLE activity (SLEDAI ≥6)
- •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):
- •Corticosteroids. Corticosteroids (< 20 mg prednisone or equivalent per day)
- •Hydroxychloroquine or equivalent anti-malarial
- •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)
- •Belimumab dose must be stable for 60 days prior to Baseline
- •Cyclophosphamide dose must be stable for the last 90 days prior to Baseline
- •Have not received rituximab within 6 months
- •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.
排除标准
- •Patients are excluded from the study if any of the following criteria are met:
- •Have rapidly progressive neurologic or renal disease
- •Currently taking an omega-3 prescription drug (e.g. Lovaza®, Vascepa®, etc.) or as medical food (e.g. Vascazen®, Vayarin, Onemia™etc.)
- •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)
- •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)
- •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
- •Have received intravenous glucocorticoids at a dosage of ≥ 500 mg daily within the past month
- •Require anti-coagulation with coumadin, clopidogrel, dalteparin, dypyridamole, enoxaparin, heparin or ticlopidine. Low dose aspirin (<325 mg/day) is permitted.
- •Receiving orlistat (Xenical, Alli) and have refused to discontinue at baseline and throughout the trial.
- •History of allergy to seafood or shellfish
- •Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Baseline
- •Are pregnant or lactating
- •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
- •Have a Grade 3 or greater laboratory abnormality based on the Adverse Event Severity Grading Tables (CTCAE), except for the following that are allowed:
- •Stable Grade 3 partial thromboplastin time (PTT) due to lupus anticoagulant and not related to liver disease or anti-coagulant therapy
- •Stable Grade 3 hypoalbuminemia due to chronic lupus nephritis, and not related to liver disease
- •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
- •Stable Grade 3 neutropenia or stable Grade 3 white blood cell count due to lupus.
- •Patients will be excluded from the study based on the following bone marrow, hepatic and renal function values:
- •Hemoglobin: < 8.0 gm/dL
- •Platelets: <50,000/mm
- •ANC < 1.0 x 103/mm
- •AST or ALT >2.5 x Upper Limit of Normal unless related to primary disease.
- •Creatinine clearance ≤ 25ml/min per 1.73m2
结局指标
主要结局
Difference in the ratio of omega-3 to omega-6 measured through lab tests on red blood cells from baseline through the end of the study in patients with generalized lupus.
时间窗: Baseline to 24 weeks
次要结局
- Change in health related quality of life measured using the Medical Outcomes study Short Form 36 (SF-36).(Baseline to 24 weeks)
- Effect of correction of omega-3 deficiency measured by SLE biomarkers of immune function.(Baseline to 24 weeks)
- Effect of correction of omega-3 deficiency measured by both clinician and patient reported outcomes collected at clinic visits.(Baseline to 24 weeks)
- Difference of number of patients with reported adverse events or changes in lab parameters while taking AKBM-3031.(Baseline to 24 weeks)
研究者
研究点 (35)
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