Phase 4
Completed N=30
Niacin and Endothelial Function in Early CKD
Source: ClinicalTrials.gov NCT00852969 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2014
Primary outcomePrimary: Change in the Flow Mediated Dilation From Baseline — 3.07; 1.37 absolute percent change — p=0.71
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Flow Mediated Dilation From Baseline |
3.07; 1.37 | 0.71 |
| SECONDARY Change in HDL-C From Baseline to 14 Weeks |
5.22; 2.74 | 0.29 |
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
Data sourced from ClinicalTrials.gov (NCT00852969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.