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

Information source: Brigham and Women's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dialysis; Cardiovascular Disease; Atherosclerosis; Inflammation

Intervention: Extended Release Nicotinic Acid (Niaspan) (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Brigham and Women's Hospital

Official(s) and/or principal investigator(s):
Kambiz ZANDI-NEJAD, MD, Principal Investigator, Affiliation: Brigham and Women's Hospital

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).

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Changes in FDG-PET/CT dual scan score

Changes in hs-CRP level

Changes in IL-6 level

Secondary outcome:

Albumin level

ESA dose requirement

Hemoglobin level

Rate of cardiovascular events

Hemodialysis access stenosis/thrombosis

Incidence of rises in liver function tests

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States

BWH/FH/DCI Outpatient Dialysis Unit, Boston, Massachusetts 02130, United States

DCI Dialysis Unit-Somerville, Somerville, Massachusetts, United States

Additional Information

Starting date: July 2010
Last updated: May 28, 2014

Page last updated: August 23, 2015

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