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

Not Applicable

Terminated

• Conditions: Atherosclerosis; Dialysis; Cardiovascular Disease; Inflammation
• Interventions: Drug: Extended Release Nicotinic Acid (Niaspan)

• Registration Number: NCT01159054
• Lead Sponsor: Brigham and Women's Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-07
• Study First Submitted QC: 2010-07-07
• Study First Posted: 2010-07-09
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2017-03-03
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-26
• Last Update Submitted: 2017-05-26
• Results First Posted: 2017-06-28
• Last Update Posted: 2017-06-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
This study has only one arm.	Extended Release Nicotinic Acid (Niaspan)	Blood sample and scan results to be compared before and after intervention in each subject.

Primary Outcome Measures

Name	Time	Method
Changes in Hs-CRP Level	6 months	Change in hs-CRP level before and after treatment in each subject
Changes in IL-6 Level	6 months	Change in IL-6 level before and after treatment in each subject
Changes in FDG-PET/CT Dual Scan Score	6 months

Secondary Outcome Measures

Name	Time	Method
Albumin Level	6 months	Pre and Post levels.
ESA (Erythorpoietic Stimulating Agent) Dose Requirement	6 months	Comparison of the average ESA dose used in the 3 month before and the last 3 months of the study.
Hemoglobin Level	6 months	Pre and Post Levels
Rate of Cardiovascular Events	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	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).	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)

Trial Locations

Locations (3)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

DCI Dialysis Unit-Somerville; 🇺🇸 Somerville, Massachusetts, United States

BWH/FH/DCI Outpatient Dialysis Unit; 🇺🇸 Boston, Massachusetts, United States