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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks.
Brigham and Women's Hospital
Boston, Massachusetts, United States
BWH/FH/DCI Outpatient Dialysis Unit
Boston, Massachusetts, United States
DCI Dialysis Unit-Somerville
Somerville, Massachusetts, United States
Changes in FDG-PET/CT Dual Scan Score
Time frame: 6 months
Changes in Hs-CRP Level
Change in hs-CRP level before and after treatment in each subject
Time frame: 6 months
Changes in IL-6 Level
Change in IL-6 level before and after treatment in each subject
Time frame: 6 months
Albumin Level
Pre and Post levels.
Time frame: 6 months
ESA (Erythorpoietic Stimulating Agent) Dose Requirement
Comparison of the average ESA dose used in the 3 month before and the last 3 months of the study.
Time frame: 6 months
Hemoglobin Level
Pre and Post Levels
Time frame: 6 months
Rate of Cardiovascular Events
Comparison of the average major cardiovascular events (myocardial infarction and/or stroke) in the 3 month before and the last 3 months of the study.
Time frame: 6 months
Hemodialysis Access Stenosis/Thrombosis
Comparison of the average hemodialysis access stenosis/thrombosis requiring intervention in the 3 month before and the last 3 months of the study.
Time frame: 6 months
Number of Completed Subjects With Significant Increase in ALT (Alanine Aminotransferase).
The number of subjects with significant rise in ALT but not to the extent requiring removal from the study (rise to more than 3 times the upper limit of the normal range)
Time frame: 6 months (checked monthly)
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