Novel Pathways to Manage Inflammation and Atherosclerosis in Dialysis Patients: Role of Nicotinic Acid
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|ClinicalTrials.gov Identifier: NCT01159054|
Recruitment Status : Terminated (The funding source is not going to fund this anymore. Only two subjects completed the study therefore meaningful analysis not possible.)
First Posted : July 9, 2010
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Dialysis Cardiovascular Disease Atherosclerosis Inflammation||Drug: Extended Release Nicotinic Acid (Niaspan)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Novel Pathways to Manage Inflammation and Atherosclerosis in Dialysis Patients: Role of Nicotinic Acid|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Experimental: This study has only one arm.
Blood sample and scan results to be compared before and after intervention in each subject.
Drug: Extended Release Nicotinic Acid (Niaspan)
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.
- Changes in FDG-PET/CT Dual Scan Score [ Time Frame: 6 months ]
- Changes in Hs-CRP Level [ Time Frame: 6 months ]Change in hs-CRP level before and after treatment in each subject
- Changes in IL-6 Level [ Time Frame: 6 months ]Change in IL-6 level before and after treatment in each subject
- Albumin Level [ Time Frame: 6 months ]Pre and Post levels.
- ESA (Erythorpoietic Stimulating Agent) Dose Requirement [ Time Frame: 6 months ]Comparison of the average ESA dose used in the 3 month before and the last 3 months of the study.
- Hemoglobin Level [ Time Frame: 6 months ]Pre and Post Levels
- Rate of Cardiovascular Events [ Time Frame: 6 months ]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.
- Hemodialysis Access Stenosis/Thrombosis [ Time Frame: 6 months ]Comparison of the average hemodialysis access stenosis/thrombosis requiring intervention in the 3 month before and the last 3 months of the study.
- Number of Completed Subjects With Significant Increase in ALT (Alanine Aminotransferase). [ Time Frame: 6 months (checked monthly) ]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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01159054
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|BWH/FH/DCI Outpatient Dialysis Unit|
|Boston, Massachusetts, United States, 02130|
|DCI Dialysis Unit-Somerville|
|Somerville, Massachusetts, United States|
|Principal Investigator:||Kambiz ZANDI-NEJAD, MD||Brigham and Women's Hospital|