Trial Outcomes & Findings for Niacin and Endothelial Function in Early CKD (NCT NCT00852969)

NCT ID: NCT00852969

Last Updated: 2014-05-06

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 30 participants
• Primary outcome timeframe: 14 weeks since baseline
• Results posted on: 2014-05-06

Participant Flow

All patients were recruited at Tufts Medical Center. Dates of recruitment were 9/2008 to 11/2011

There was no washout period. Patients receiving Niacin were excluded from the study.

Participant milestones

Measure	Niacin Niacin : 1000 mg tablets once per day	Placebo Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
Overall Study STARTED	15	15
Overall Study COMPLETED	15	13
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Niacin Niacin : 1000 mg tablets once per day	Placebo Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
Overall Study Adverse Event	0	1
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Niacin and Endothelial Function in Early CKD

Baseline characteristics by cohort

Measure	Niacin n=15 Participants Niacin : 1000 mg tablets once per day	Placebo n=15 Participants Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Age, Continuous	58.1 years STANDARD_DEVIATION 10.9 • n=5 Participants	50.4 years STANDARD_DEVIATION 11.9 • n=7 Participants	54.2 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 weeks since baseline

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

Outcome measures

Measure	Niacin n=15 Participants Niacin : 1000 mg tablets once per day	Placebo n=13 Participants Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
Change in the Flow Mediated Dilation From Baseline	3.07 absolute percent change Interval -2.36 to 8.5	1.37 absolute percent change Interval -6.81 to 9.56

SECONDARY outcome

Timeframe: 14 weeks since baseline

Outcome measures

Measure	Niacin n=15 Participants Niacin : 1000 mg tablets once per day	Placebo n=15 Participants Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
Change in HDL-C From Baseline to 14 Weeks	5.22 mg/dl Interval 1.19 to 9.25	2.74 mg/dl Interval -0.13 to 5.61

Adverse Events

Niacin

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Niacin n=15 participants at risk Niacin : 1000 mg tablets once per day	Placebo n=15 participants at risk Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
Skin and subcutaneous tissue disorders flushing	66.7% 10/15 • Number of events 10 • During the trial up to 14 weeks	33.3% 5/15 • Number of events 5 • During the trial up to 14 weeks
Gastrointestinal disorders diarrhea	13.3% 2/15 • Number of events 2 • During the trial up to 14 weeks	0.00% 0/15 • During the trial up to 14 weeks
Gastrointestinal disorders constipation	0.00% 0/15 • During the trial up to 14 weeks	33.3% 5/15 • Number of events 5 • During the trial up to 14 weeks
Gastrointestinal disorders nausea	6.7% 1/15 • Number of events 1 • During the trial up to 14 weeks	0.00% 0/15 • During the trial up to 14 weeks
Musculoskeletal and connective tissue disorders joint pains	6.7% 1/15 • Number of events 1 • During the trial up to 14 weeks	0.00% 0/15 • During the trial up to 14 weeks

Additional Information

Mark Sarnak, MD

Tufts Medical Center

Phone: 617 636-1182

Email: msarnak@tuftsmedicalcenter.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place