NCT01238588终止不适用
The Effect(s) of Sevelamer Carbonate (Renvela) on Atherosclerotic Plaque Inflammation Judged by FDG-PET Scan
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 10
- 主要终点
- Changes in Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET): FDG-PET/CT Dual Scan Score
研究概览
简要总结
The hypothesis is that switching calcium based phosphate binders to sevelamer carbonate will be associated with less inflammation including less atherosclerotic plaque inflammation (inflammation of the vessel walls).
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
- 50 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, 50 years or older;
- •Diagnosed with end stage renal disease (ESRD), on maintenance hemodialysis for at least three (3) months;
- •On calcium-based phosphate binders;
- •Subject must be able to understand and provide informed consent;
- •No known contraindications to therapy with sevelamer carbonate.
排除标准
- •Any patient with a medical condition or taking any medications that would be contraindicated with the use of sevelamer carbonate, such as history of bowel obstruction;
- •History of severe allergic reactions to the study medication;
- •History of active infection (other than a simple respiratory tract infection) or acute gouty attack within 2 weeks prior to enrollment;
- •Known serological positivity for Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen (HBsAg), or Hepatitis C Virus Antibody (HCV Ab) except dose with normal liver function tests (AST, ALT, Bilirubin, and Alkaline Phophatase) and no history of cirrhosis;
- •Elevation of liver function tests at time of entry (Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (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 those adequately treated, has completed treatment and clinically in remission for more than 6 month; adequately treated in-situ cervical carcinoma, or adequately treated basal or squamous cell carcinoma of the skin;
- •History of an inflammatory disease such as systemic lupus erythematosus (SLE), rheumatoid arthritis or ulcerative colitis except those in remission for more than 6 months;
- •Patients currently on sevelamer carbonate or sevelamer chloride or history of taking them for more than a week in the past three months;
- •Patients receiving chronic anti-inflammatory therapy;
- •Patients in whom FDG-PET/CT dual scans are contraindicated.
研究组 & 干预措施
Sevelamer Carbonate (Renvela)
Other
Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.
干预措施: Sevelamer Carbonate (Renvela) (Drug)
结局指标
主要结局
Changes in Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET): FDG-PET/CT Dual Scan Score
时间窗: Baseline and 6 months
Changes in High Sensitivity C-Reactive Protein (Hs-CRP) Level
时间窗: Baseline and 6 months
Changes in Interleukin-6 (IL-6) Level
时间窗: Baseline and 6 months
次要结局
- Albumin Levels(Baseline and 6 months)
- Erythropoiesis Stimulating Agent (ESA) Dose Requirement(Baseline and 6 months)
- Hemoglobin Level(Baseline and 6 months)
- Rate of Cardiovascular Events(Baseline and 6 months)
- Hemodialysis Access Stenosis/Thrombosis(Baseline and 6 months)
研究者
Kambiz Zandi-Nejad, MD
Instructor in Medicine
Brigham and Women's Hospital
研究点 (10)
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