Novel Pathways to Manage Inflammation and Atherosclerosis in Dialysis Patients: Role of Nicotinic Acid
Overview
- Phase
- Not Applicable
- Intervention
- Extended Release Nicotinic Acid (Niaspan)
- Conditions
- Dialysis
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 22
- Locations
- 3
- Primary Endpoint
- Changes in Hs-CRP Level
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
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).
Investigators
Kambiz Zandi-Nejad, MD
Instructor in Medicine
Brigham and Women's Hospital
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
Arms & Interventions
This study has only one arm.
Blood sample and scan results to be compared before and after intervention in each subject.
Intervention: Extended Release Nicotinic Acid (Niaspan)
Outcomes
Primary Outcomes
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
Changes in FDG-PET/CT Dual Scan Score
Time Frame: 6 months
Secondary Outcomes
- 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))