Clinical trial NCT01159054: Novel Pathways to Manage Inflammation and Atherosclerosis in Dialysis Patients: Role of Nicotinic Acid
Official title: Novel Pathways to Manage Inflammation and Atherosclerosis in Dialysis Patients: Role of Nicotinic Acid
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dialysis
Cardiovascular Disease
Atherosclerosis
Inflammation
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2010-07-09
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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;
* 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)

Primary outcomes:
measure: Changes in FDG-PET/CT Dual Scan Score
timeFrame: 6 months
measure: Changes in Hs-CRP Level
timeFrame: 6 months
measure: Changes in IL-6 Level
timeFrame: 6 months
Secondary outcomes:
measure: Albumin Level
timeFrame: 6 months
measure: ESA (Erythorpoietic Stimulating Agent) Dose Requirement
timeFrame: 6 months
measure: Hemoglobin Level
timeFrame: 6 months
measure: Rate of Cardiovascular Events
timeFrame: 6 months
measure: Hemodialysis Access Stenosis/Thrombosis
timeFrame: 6 months
measure: Number of Completed Subjects With Significant Increase in ALT (Alanine Aminotransferase).
timeFrame: 6 months (checked monthly)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: BWH/FH/DCI Outpatient Dialysis Unit
state: Massachusetts
city: Somerville
country: United States
facility: DCI Dialysis Unit-Somerville
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Kambiz ZANDI-NEJAD, MD
role: PRINCIPAL_INVESTIGATOR
References: