Novel Pathways to Manage Inflammation and Atherosclerosis in Dialysis Patients: Role of Nicotinic Acid

Stopped early · Not applicable

Conditions studied: Dialysis, Cardiovascular Disease, Atherosclerosis, Inflammation

In brief

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).

Key facts

Study ID

NCT01159054

Run by

Brigham and Women's Hospital

People needed

22

Starts

2010-07-01

Expected to finish

2014-12-01

Last updated by the study team

2017-06-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;
• Patients currently on pharmacological doses of nicotinic acid;
• Patients receiving chronic anti-inflammatory therapy;
• Patients with average baseline hs-CRP levels of > 20 mg/L or < 1 mg/L;
• Patients in whom FDG-PET/CT dual scans are contraindicated (e.g., pregnant patients or those with severe allergy to IV contrast; a pregnancy test will be performed in each female subject between 18 and 45 years of age prior to each scan)

Where it is running

• 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

Full record on ClinicalTrials.gov

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