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

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ClinicalTrials.gov Identifier: NCT01159054
Recruitment Status : Terminated (The funding source is not going to fund this anymore. Only two subjects completed the study therefore meaningful analysis not possible.)
First Posted : July 9, 2010
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
Kambiz Zandi-Nejad, MD, Brigham and Women's Hospital

Study Description
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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).

Condition or disease Intervention/treatment Phase
Dialysis Cardiovascular Disease Atherosclerosis Inflammation Drug: Extended Release Nicotinic Acid (Niaspan) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Novel Pathways to Manage Inflammation and Atherosclerosis in Dialysis Patients: Role of Nicotinic Acid
Study Start Date : July 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: This study has only one arm.
Blood sample and scan results to be compared before and after intervention in each subject.
 Drug: Extended Release Nicotinic Acid (Niaspan)
Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks.
Other Names:
  • Extended Release Nicotinic Acid
  • Niaspan


Outcome Measures
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Primary Outcome Measures :
  1. Changes in FDG-PET/CT Dual Scan Score [ Time Frame: 6 months ]
  2. Changes in Hs-CRP Level [ Time Frame: 6 months ]
    Change in hs-CRP level before and after treatment in each subject

  3. Changes in IL-6 Level [ Time Frame: 6 months ]
    Change in IL-6 level before and after treatment in each subject


Secondary Outcome Measures :
  1. Albumin Level [ Time Frame: 6 months ]
    Pre and Post levels.

  2. ESA (Erythorpoietic Stimulating Agent) Dose Requirement [ Time Frame: 6 months ]
    Comparison of the average ESA dose used in the 3 month before and the last 3 months of the study.

  3. Hemoglobin Level [ Time Frame: 6 months ]
    Pre and Post Levels

  4. Rate of Cardiovascular Events [ Time Frame: 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.

  5. Hemodialysis Access Stenosis/Thrombosis [ Time Frame: 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.

  6. Number of Completed Subjects With Significant Increase in ALT (Alanine Aminotransferase). [ Time Frame: 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01159054


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
BWH/FH/DCI Outpatient Dialysis Unit
Boston, Massachusetts, United States, 02130
DCI Dialysis Unit-Somerville
Somerville, Massachusetts, United States
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Kambiz ZANDI-NEJAD, MD Brigham and Women's Hospital
More Information
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Responsible Party: Kambiz Zandi-Nejad, MD, Instructor in Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01159054    
Other Study ID Numbers: 2010P001049
First Posted: July 9, 2010    Key Record Dates
Results First Posted: June 28, 2017
Last Update Posted: June 28, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Cardiovascular Diseases
Atherosclerosis
Inflammation
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Niacin
Nicotinic Acids
Niacinamide
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs