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临床试验/NCT02764736
NCT02764736撤回不适用

Atorvastatin Reduces Chronic Inflammation and aVerage Epogen Dose (ARChIVED)

Albert Einstein Healthcare Network0 个研究点开始时间: 2016年3月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
主要终点
Epoetin alfa (Epogen) utilization measured in units per week

研究概览

简要总结

The specific aim of this trial is to determine whether initiating moderate- or high-intensity atorvastatin therapy in hemodialysis patient not previously on a statin reduces inflammation and lowers average Epogen utilization. Statin naive patients on maintenance HD will be started on 20mg atorvastatin daily for weeks and then titrated up to 40mg atorvastatin daily for an additional 12 weeks. Patient's inflammatory markers (ferritin, CRP) and weekly Epogen usage will be monitored.

详细描述

Patients will be identified and consented. After informed consent is obtained, baseline demographic information, past medical history, dialysis specific information, and laboratory metrics (lipid profile, inflammatory markers) will be obtained from the electronic medical records. For the first 12 weeks, all subjects will be instructed to take one 20mg atorvastatin tablet daily; atorvastatin tablets will be dispensed by the research team in 30-tablet increments every month to ensure compliance and prevent diversion. Subjects will undergo standard-of-care hemodialysis with routine hemoglobin monitoring and Epogen titration according to the dialysis center protocol. Every two weeks, they will be assessed by a research coordinator who will monitor for medication adverse effects (see attached patient survey) and medication compliance (pill counts) at alternating visits. After 12 weeks, lipid profile and inflammatory markers will be rechecked or obtained from the electronic medical record. For the subsequent 12 weeks (ie. weeks 12-24), subjects will be instructed to take two 20mg atorvastatin tablets (40mg total) daily. If the subject is unable to tolerate 40mg of atorvastatin daily due to medication adverse effects, they will continue to take 20mg atorvastatin daily for the remainder of the trial. Epogen will be titrated and subjects will be monitored as above. At the completion of the study, a lipid panel and inflammatory markers will be checked for a third time. Epogen usage and dialysis specific information will be recorded continuously throughout the study.

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

盲法说明

Open label study

入排标准

年龄范围
18 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stable on Hemoglobin levels on Epogen therapy (Hgb between 9.5-11.5 for prior 3 weeks)
  • No statin usage during the prior 3 months
  • Complaint with hemodialysis and medications

排除标准

  • Prior history of myocardial infarction, stroke or vascular disease
  • Prior hospitalization within the past 15 days
  • Prior episodes of significant bleeding (trauma, GI bleed, GU bleed, menorrhagia) in the prior 15 days
  • Liver disease
  • Active malignancy
  • Hematologic disorder

研究组 & 干预措施

atorvastatin

Experimental

Patients in this arm will receive 20mg atorvastatin PO daily for 12 weeks followed by 40mg atorvastatin PO daily for 12 weeks.

干预措施: Atorvastatin (Drug)

结局指标

主要结局

Epoetin alfa (Epogen) utilization measured in units per week

时间窗: 24 weeks

The amount of epoetin alfa, measured in units, needed to maintain a patient's hemoglobin between 11.0 and 12.0 gm/dL

次要结局

  • Total cholesterol level, LDL level, HDL level(24 weeks)
  • C-reactive protein, ferritin levels(24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pradhum Ram

Principal investigator

Albert Einstein Healthcare Network

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