Novel Pathways to Manage Inflammation and Atherosclerosis in Dialysis Patients: Role of Nicotinic Acid
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 3
- 主要终点
- Changes in Hs-CRP Level
研究概览
简要总结
Patients with kidney failure on hemodialysis have an extremely high rate of cardiovascular disease including atherosclerotic cardiovascular disease. This, at least in part, is due to the chronic inflammatory status usually seen in these patients. Here we try to see if treatment with extended release nicotinic acid (Niaspan) can reduce their overall inflammatory burden (in general) and the atherosclerotic plaque inflammation (in particular).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •A signed consent form;
- •Male or Female, 18 years or older;
- •Diagnosed with ESRD, on maintenance hemodialysis for at least six (6) months;
- •Subject must be able to understand and provide informed consent;
- •No known contraindications to therapy with nicotinic acid;
- •Female subjects of childbearing potential must be willing to be on an acceptable form of birth control for the duration of the study and for two month after they have stopped taking the study drug.
排除标准
- •Any patient with a medical condition or taking any medications that would be contraindicated with the use of extended release niacin, such as active peptic ulcer disease;
- •History of severe allergic reactions to the study medication;
- •History of active infection or acute gouty attack within 2 weeks prior to enrollment;
- •Known serological positivity for HIV, HBsAg, or HCV Ab;
- •HbA1C > 9;
- •Total CK of more than three times of the upper limit of normal;
- •Elevation of liver function tests at time of entry (AST and/or ALT > 2 times the upper limit of normal);
- •History of drug, alcohol, or chemical abuse within 6 months prior to enrollment;
- •History of malignancy except adequately treated in-situ cervical carcinoma, or adequately treated basal or squamous cell carcinoma of the skin;
- •History of an inflammatory disease such as SLE, rheumatoid arthritis or ulcerative colitis;
- •Patients currently on pharmacological doses of nicotinic acid;
- •Patients receiving chronic anti-inflammatory therapy;
- •Patients with average baseline hs-CRP levels of > 20 mg/L or < 1 mg/L;
- •Patients in whom FDG-PET/CT dual scans are contraindicated (e.g., pregnant patients or those with severe allergy to IV contrast; a pregnancy test will be performed in each female subject between 18 and 45 years of age prior to each scan)
研究组 & 干预措施
This study has only one arm.
Blood sample and scan results to be compared before and after intervention in each subject.
干预措施: Extended Release Nicotinic Acid (Niaspan) (Drug)
结局指标
主要结局
Changes in Hs-CRP Level
时间窗: 6 months
Change in hs-CRP level before and after treatment in each subject
Changes in IL-6 Level
时间窗: 6 months
Change in IL-6 level before and after treatment in each subject
Changes in FDG-PET/CT Dual Scan Score
时间窗: 6 months
次要结局
- Albumin Level(6 months)
- ESA (Erythorpoietic Stimulating Agent) Dose Requirement(6 months)
- Hemoglobin Level(6 months)
- Rate of Cardiovascular Events(6 months)
- Hemodialysis Access Stenosis/Thrombosis(6 months)
- Number of Completed Subjects With Significant Increase in ALT (Alanine Aminotransferase).(6 months (checked monthly))
研究者
Kambiz Zandi-Nejad, MD
Instructor in Medicine
Brigham and Women's Hospital