Chronic Kidney Disease
Conditions
Keywords
Chronic Kidney Disease, Niacin, HDL, Endothelial Function
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.
Interventions
DRUGNiacin
1000 mg tablets once per day
DRUGActive Placebo
100 mg Niacin tablets once per day
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Tufts Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Flow Mediated Dilation From Baseline | 14 weeks since baseline | Flow mediated dilation by brachial artery reactivity at baseline versus 14 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in HDL-C From Baseline to 14 Weeks | 14 weeks since baseline |
Countries
United States
Participant flow
Recruitment details
All patients were recruited at Tufts Medical Center. Dates of recruitment were 9/2008 to 11/2011
Pre-assignment details
There was no washout period. Patients receiving Niacin were excluded from the study.
Participants by arm
| Arm | Count |
|---|---|
| Niacin Niacin : 1000 mg tablets once per day | 15 |
| Placebo Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Niacin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 5 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 10 Participants | 23 Participants |
| Age, Continuous | 50.4 years STANDARD_DEVIATION 11.9 | 58.1 years STANDARD_DEVIATION 10.9 | 54.2 years STANDARD_DEVIATION 11.9 |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 11 Participants | 6 Participants | 17 Participants |
| Sex: Female, Male Male | 4 Participants | 9 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 15 | 5 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Niacin | Change in the Flow Mediated Dilation From Baseline | 3.07 absolute percent change |
| Placebo | Change in the Flow Mediated Dilation From Baseline | 1.37 absolute percent change |
p-value: 0.7195% CI: [-10.79, 7.41]t-test, 2 sided
Secondary
Change in HDL-C From Baseline to 14 Weeks
Time frame: 14 weeks since baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Niacin | Change in HDL-C From Baseline to 14 Weeks | 5.22 mg/dl |
| Placebo | Change in HDL-C From Baseline to 14 Weeks | 2.74 mg/dl |
p-value: 0.2995% CI: [-7.2, 2.24]t-test, 2 sided