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Niacin and Endothelial Function in Early CKD

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00852969
First received: February 26, 2009
Last updated: June 25, 2012
Last verified: June 2012
History of Changes

February 26, 2009
June 25, 2012
August 2008
April 2012   (final data collection date for primary outcome measure)
Flow mediated dilation [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00852969 on ClinicalTrials.gov Archive Site
HDL-C and other lipid subclasses [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Same as current
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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
 
Completed
30
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
Both
21 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00852969
5R21DK077368, 5R21DK077368-02
Yes
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
June 2012

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