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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

Tracking Information
First Submitted Date  ICMJE July 7, 2010
First Posted Date  ICMJE July 9, 2010
Results First Submitted Date  ICMJE March 3, 2017
Results First Posted Date  ICMJE June 28, 2017
Last Update Posted Date June 28, 2017
Study Start Date  ICMJE July 2010
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2017)
  • Changes in FDG-PET/CT Dual Scan Score [ Time Frame: 6 months ]
  • Changes in Hs-CRP Level [ Time Frame: 6 months ]
    Change in hs-CRP level before and after treatment in each subject
  • Changes in IL-6 Level [ Time Frame: 6 months ]
    Change in IL-6 level before and after treatment in each subject
Original Primary Outcome Measures  ICMJE
 (submitted: July 7, 2010)
  • Changes in FDG-PET/CT dual scan score [ Time Frame: 6 months ]
  • Changes in hs-CRP level [ Time Frame: 6 monhts ]
  • Changes in IL-6 level [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2017)
  • Albumin Level [ Time Frame: 6 months ]
    Pre and Post levels.
  • 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.
  • Hemoglobin Level [ Time Frame: 6 months ]
    Pre and Post Levels
  • 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.
  • 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.
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2010)
  • Albumin level [ Time Frame: 6 months ]
  • ESA dose requirement [ Time Frame: 6 months ]
  • Hemoglobin level [ Time Frame: 6 months ]
  • Rate of cardiovascular events [ Time Frame: 6 months ]
  • Hemodialysis access stenosis/thrombosis [ Time Frame: 6 months ]
  • Incidence of rises in liver function tests [ Time Frame: 6 months (checked monthly) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Novel Pathways to Manage Inflammation and Atherosclerosis in Dialysis Patients: Role of Nicotinic Acid
Official Title  ICMJE Novel Pathways to Manage Inflammation and Atherosclerosis in Dialysis Patients: Role of Nicotinic Acid
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Dialysis
  • Cardiovascular Disease
  • Atherosclerosis
  • Inflammation
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: This study has only one arm.
Blood sample and scan results to be compared before and after intervention in each subject.
Intervention: Drug: Extended Release Nicotinic Acid (Niaspan)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 28, 2014)
22
Original Estimated Enrollment  ICMJE
 (submitted: July 7, 2010)
32
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01159054
Other Study ID Numbers  ICMJE 2010P001049
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Kambiz Zandi-Nejad, MD, Brigham and Women's Hospital
Original Responsible Party Kambiz ZANDI-NEJAD, MD, Brigham and Women's Hospital
Current Study Sponsor  ICMJE Brigham and Women's Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kambiz ZANDI-NEJAD, MD Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP