Niacin and Endothelial Function in Early CKD

Tufts Medical Center30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chronic Kidney Disease

Interventions

NiacinDRUG

1000 mg tablets once per day

Active PlaceboDRUG

100 mg Niacin tablets once per day

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Tufts Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Change in the Flow Mediated Dilation From Baseline

Flow mediated dilation by brachial artery reactivity at baseline versus 14 weeks

Time frame: 14 weeks since baseline

Secondary Outcomes

Change in HDL-C From Baseline to 14 Weeks

Time frame: 14 weeks since baseline

Data from ClinicalTrials.gov

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