Status:
COMPLETED
Niacin and Endothelial Function in Early CKD
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
21-80 years
Phase:
PHASE4
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 understa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00852969
Start Date
August 1 2008
End Date
April 1 2012
Last Update
May 6 2014
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111