Trial Outcomes & Findings for Novel Pathways to Manage Inflammation and Atherosclerosis in Dialysis Patients: Role of Nicotinic Acid (NCT NCT01159054)

NCT ID: NCT01159054

Last Updated: 2017-06-28

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2017-06-28

Participant Flow

Participant milestones

Measure	Treatment Group (One Arm Only Study) Blood sample and scan results to be compared before and after intervention in each subject. Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks.
Overall Study STARTED	22
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Novel Pathways to Manage Inflammation and Atherosclerosis in Dialysis Patients: Role of Nicotinic Acid

Baseline characteristics by cohort

Measure	Treatment Group (One Arm Only Study) n=22 Participants Blood sample and scan results to be compared before and after intervention in each subject. Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	58.9 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Analysis of images for this outcome measure was not done given than only 2 subjects had completed the study at the time of the study early termination and closure (per funding source)

Outcome measures

Measure

Treatment Group (One Arm Only Study) Blood sample and scan results to be compared before and after intervention in each subject. Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks.

Changes in FDG-PET/CT Dual Scan Score

0

PRIMARY outcome

Timeframe: 6 months

Population: Only 2 subjects completed the study. Power for further analysis was not met.

Change in hs-CRP level before and after treatment in each subject

Outcome measures

Measure	Treatment Group (One Arm Only Study) n=2 Participants Blood sample and scan results to be compared before and after intervention in each subject. Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks.
Changes in Hs-CRP Level Average Pre-Treatment	18.465 mg/L Interval 9.09 to 27.84
Changes in Hs-CRP Level Average Post-Treatment	26.395 mg/L Interval 8.76 to 44.03

PRIMARY outcome

Timeframe: 6 months

Population: Only 2 subjects completed the study. Further analysis not done because power was not met.

Change in IL-6 level before and after treatment in each subject

Outcome measures

Measure	Treatment Group (One Arm Only Study) n=2 Participants Blood sample and scan results to be compared before and after intervention in each subject. Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks.
Changes in IL-6 Level Average Pre-Treatment	5.1254 pg/mL Interval 1.962 to 8.287
Changes in IL-6 Level Average Post-Treatment	14.8375 pg/mL Interval 3.152 to 26.523

SECONDARY outcome

Timeframe: 6 months

Population: Only 2 subjects completed the study. Further analysis was not done because power was not met.

Pre and Post levels.

Outcome measures

Measure	Treatment Group (One Arm Only Study) n=2 Participants Blood sample and scan results to be compared before and after intervention in each subject. Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks.
Albumin Level Average Pre-Treatment	3.9 g/dL Interval 3.9 to 3.9
Albumin Level Average Post-Treatment	4.05 g/dL Interval 3.8 to 4.3

SECONDARY outcome

Timeframe: 6 months

Population: Data for this outcome measure was not collected.

Comparison of the average ESA dose used in the 3 month before and the last 3 months of the study.

Outcome measures

Measure

Treatment Group (One Arm Only Study) Blood sample and scan results to be compared before and after intervention in each subject. Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks.

ESA (Erythorpoietic Stimulating Agent) Dose Requirement

0

SECONDARY outcome

Timeframe: 6 months

Population: Only 2 subjects completed the study. Further analysis was not done because power was not met.

Pre and Post Levels

Outcome measures

Measure	Treatment Group (One Arm Only Study) n=2 Participants Blood sample and scan results to be compared before and after intervention in each subject. Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks.
Hemoglobin Level Average Pre-Treatment	11.6 g/dL Interval 10.9 to 12.3
Hemoglobin Level Average Post-Treatment	10.15 g/dL Interval 9.3 to 11.0

SECONDARY outcome

Timeframe: 6 months

Population: Data for this outcome measure was not collected from the medical record due to early termination of the study.

Comparison of the average major cardiovascular events (myocardial infarction and/or stroke) in the 3 month before and the last 3 months of the study.

Outcome measures

Measure

Treatment Group (One Arm Only Study) Blood sample and scan results to be compared before and after intervention in each subject. Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks.

Rate of Cardiovascular Events

0

SECONDARY outcome

Timeframe: 6 months

Population: Data for this outcome measure was not collected from the medical record due to early termination of the study.

Comparison of the average hemodialysis access stenosis/thrombosis requiring intervention in the 3 month before and the last 3 months of the study.

Outcome measures

Measure

Treatment Group (One Arm Only Study) Blood sample and scan results to be compared before and after intervention in each subject. Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks.

Hemodialysis Access Stenosis/Thrombosis

0

SECONDARY outcome

Timeframe: 6 months (checked monthly)

The number of subjects with significant rise in ALT but not to the extent requiring removal from the study (rise to more than 3 times the upper limit of the normal range)

Outcome measures

Measure

Treatment Group (One Arm Only Study) n=2 Participants Blood sample and scan results to be compared before and after intervention in each subject. Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks.

Number of Completed Subjects With Significant Increase in ALT (Alanine Aminotransferase).

0 Participants

Adverse Events

Treatment Group (One Arm Only Study)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure

Treatment Group (One Arm Only Study) n=22 participants at risk Blood sample and scan results to be compared before and after intervention in each subject. Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks.

Cardiac disorders Atrial Fibrillation

4.5% 1/22 • Number of events 1 • 6 months (the time between the first and the second scan)

Other adverse events

Measure	Treatment Group (One Arm Only Study) n=22 participants at risk Blood sample and scan results to be compared before and after intervention in each subject. Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks.
Skin and subcutaneous tissue disorders Flushing	9.1% 2/22 • Number of events 2 • 6 months (the time between the first and the second scan)
Gastrointestinal disorders GI upset	4.5% 1/22 • Number of events 1 • 6 months (the time between the first and the second scan)

Additional Information

Kambiz Zandi-Nejad

Brigham and Women's Hospital

Phone: 617-732-6660

Email: kzandinejad@partners.org

Results disclosure agreements

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