Niacin and Endothelial Function in Early CKD
Information source: Tufts Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Kidney Disease
Intervention: Niacin (Drug); Active Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Tufts Medical Center Official(s) and/or principal investigator(s):
Mark Sarnak, MD, Principal Investigator, Affiliation: Tufts Medical Center
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.
Clinical Details
Official title: Does Raising HDL-C With Niacin Improve Endothelial Function in Early CKD?
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in the Flow Mediated Dilation From Baseline
Secondary outcome: Change in HDL-C From Baseline to 14 Weeks
Eligibility
Minimum age: 21 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Tufts Medical Center, Boston, Massachusetts 02111, United States
Additional Information
Starting date: August 2008
Last updated: April 3, 2014
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