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Niacin and Endothelial Function in Early CKD

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Niacin
Active Placebo
Sponsored by
Tufts Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic Kidney Disease, Niacin, HDL, Endothelial Function

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tufts Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Niacin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in the Flow Mediated Dilation From Baseline
Flow mediated dilation by brachial artery reactivity at baseline versus 14 weeks

Secondary Outcome Measures

Change in HDL-C From Baseline to 14 Weeks

Full Information

First Posted
February 26, 2009
Last Updated
April 3, 2014
Sponsor
Tufts Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00852969
Brief Title
Niacin and Endothelial Function in Early CKD
Official Title
Does Raising HDL-C With Niacin Improve Endothelial Function in Early CKD?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Chronic Kidney Disease, Niacin, HDL, Endothelial Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Niacin
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Niacin
Other Intervention Name(s)
Niaspan
Intervention Description
1000 mg tablets once per day
Intervention Type
Drug
Intervention Name(s)
Active Placebo
Intervention Description
100 mg Niacin tablets once per day
Primary Outcome Measure Information:
Title
Change in the Flow Mediated Dilation From Baseline
Description
Flow mediated dilation by brachial artery reactivity at baseline versus 14 weeks
Time Frame
14 weeks since baseline
Secondary Outcome Measure Information:
Title
Change in HDL-C From Baseline to 14 Weeks
Time Frame
14 weeks since baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Sarnak, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Niacin and Endothelial Function in Early CKD

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