Niacin and Endothelial Function in Early CKD

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00852969
First received: February 26, 2009
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Chronic Kidney Disease
Drug: Niacin
Drug: Active Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Raising HDL-C With Niacin Improve Endothelial Function in Early CKD?

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • Change in the Flow Mediated Dilation From Baseline [ Time Frame: 14 weeks since baseline ] [ Designated as safety issue: No ]
    Flow mediated dilation by brachial artery reactivity at baseline versus 14 weeks


Secondary Outcome Measures:
  • Change in HDL-C From Baseline to 14 Weeks [ Time Frame: 14 weeks since baseline ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: August 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852969

Locations
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Investigators
Principal Investigator: Mark Sarnak, MD Tufts Medical Center
  More Information

No publications provided

Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00852969     History of Changes
Other Study ID Numbers: 5R21DK077368, 5R21DK077368-02
Study First Received: February 26, 2009
Results First Received: November 27, 2013
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts Medical Center:
Chronic Kidney Disease
Niacin
HDL
Endothelial Function

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Niacin
Nicotinic Acids
Niacinamide
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Vasodilator Agents
Cardiovascular Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014