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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
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Tufts Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Niacin Drug: Active Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Raising HDL-C With Niacin Improve Endothelial Function in Early CKD?
Study Start Date : August 2008
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012


Arm Intervention/treatment
Active Comparator: Niacin Drug: Niacin
1000 mg tablets once per day
Other Name: Niaspan

Placebo Comparator: Placebo Drug: Active Placebo
100 mg Niacin tablets once per day




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in HDL-C From Baseline to 14 Weeks [ Time Frame: 14 weeks since baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00852969


Locations
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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Mark Sarnak, MD Tufts Medical Center
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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00852969    
Other Study ID Numbers: 5R21DK077368 ( U.S. NIH Grant/Contract )
5R21DK077368-02 ( U.S. NIH Grant/Contract )
First Posted: February 27, 2009    Key Record Dates
Results First Posted: May 6, 2014
Last Update Posted: May 6, 2014
Last Verified: April 2014
Keywords provided by Tufts Medical Center:
Chronic Kidney Disease
Niacin
HDL
Endothelial Function
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Niacin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs