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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: Niacin; Drug: Active Placebo

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Active Placebo; 100 mg Niacin tablets once per day
Active Comparator: Niacin	Drug: Niacin; 1000 mg tablets once per day; Other Names: Niaspan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Flow Mediated Dilation From Baseline	Flow mediated dilation by brachial artery reactivity at baseline versus 14 weeks	14 weeks since baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in HDL-C From Baseline to 14 Weeks	14 weeks since baseline

Collaborators and Investigators

• Sponsor: Tufts Medical Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Mark Sarnak, MD, Tufts Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: February 26, 2009
• First Submitted That Met QC Criteria: February 26, 2009
• First Posted (Estimate): February 27, 2009

Study Record Updates

• Last Update Posted (Estimate): May 6, 2014
• Last Update Submitted That Met QC Criteria: April 3, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Endothelial Function; Chronic Kidney Disease; HDL; Niacin
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Niacin
• Other Study ID Numbers: 5R21DK077368 (U.S. NIH Grant/Contract); 5R21DK077368-02 (U.S. NIH Grant/Contract)