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Niacin and Endothelial Function in Early CKD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00852969
Recruitment Status : Completed
First Posted : February 27, 2009
Results First Posted : May 6, 2014
Last Update Posted : May 6, 2014
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Tufts Medical Center

February 26, 2009
February 27, 2009
November 27, 2013
May 6, 2014
May 6, 2014
August 2008
April 2012   (Final data collection date for primary outcome measure)
Change in the Flow Mediated Dilation From Baseline [ Time Frame: 14 weeks since baseline ]
Flow mediated dilation by brachial artery reactivity at baseline versus 14 weeks
Flow mediated dilation [ Time Frame: 14 weeks ]
Complete list of historical versions of study NCT00852969 on ClinicalTrials.gov Archive Site
Change in HDL-C From Baseline to 14 Weeks [ Time Frame: 14 weeks since baseline ]
HDL-C and other lipid subclasses [ Time Frame: 14 weeks ]
Not Provided
Not Provided
Niacin and Endothelial Function in Early CKD
Does Raising HDL-C With Niacin Improve Endothelial Function in Early CKD?
The purpose of this study is to obtain information on whether raising levels of HDL-cholesterol (the "good" cholesterol) can improve how blood vessels work in kidney disease. This may help us understand the causes leading to high rates of heart disease in kidney disease and also ways to reduce this risk.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Kidney Disease
  • Drug: Niacin
    1000 mg tablets once per day
    Other Name: Niaspan
  • Drug: Active Placebo
    100 mg Niacin tablets once per day
  • Active Comparator: Niacin
    Intervention: Drug: Niacin
  • Placebo Comparator: Placebo
    Intervention: Drug: Active Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
April 2012
April 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of CKD Stage 2 (GFR >60 and microalbuminuria/proteinuria) and Stage 3-4 (GFR 15-30)
  • HDL-cholesterol <50 for men and <55 for women
  • If taking a statin, stable dose for past one month
  • Glucose <200 mg/dL and HbA1c <9%
  • Transplant recipients who are in stage 2-3 CKD; 1-year post transplant; and have had no rejection episodes in the 6-months prior to study entry

Exclusion Criteria:

  • Hospitalization within prior 3 months
  • Any of the following conditions:

    • uncontrolled peptic ulcer disease
    • active liver disease OR abnormal SGOT/SGPT
    • history of adverse reaction to niacin
    • contra-indication to aspirin
    • concurrent fibrate therapy
    • history of gout
    • serum phosphorus levels below 2.7mg/dl
  • Nursing
  • Pregnancy
Sexes Eligible for Study: All
21 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
5R21DK077368( U.S. NIH Grant/Contract )
5R21DK077368-02 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Tufts Medical Center
Tufts Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Mark Sarnak, MD Tufts Medical Center
Tufts Medical Center
April 2014

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